Site Master File
- General Information on the Manufacturer
- Contact information on the manufacturer
- Name and official address of the manufacturer
- Names and street addresses of the site, buildings and production units located on the site
- Contact information of the manufacturer including telephone, fax, email and 24 hours telephone numbers
- Name and number of the contact personnel in the case of product defects or recalls
- Authorised pharmaceutical manufacturing activities of the site.
- Brief description of manufacture, import, export, distribution and other activities as authorised by the relevant Competent Authorities including foreign authorities with authorised dosage forms/activities, respectively; where not covered by the manufacturing authorisation
- Type of products currently manufactured on-site (list in Appendix 2)
- List of GMP inspections of the site within the last 5 years, including dates and name/country of the Competent Authority having performed the inspection. A copy of current GMP certificate (Appendix 3)
- Any other manufacturing activities carried out on the site
- Description of non-pharmaceutical activities on-site, if any
- Contact information on the manufacturer
- Quality Management System of the Manufacturer
- The quality management system of the manufacturer
- Brief description of the quality management systems run by the company and reference to the standards used
- Responsibilities related to the maintaining of quality system including senior management
- Information of activities for which the site is accredited and certified, including dates and contents of accreditations, names of accrediting bodies
- Release procedure of finished products
- Detailed description of qualification requirements (education and work experience) of the Authorised Person(s) / Qualified Person(s) responsible for batch certification and releasing procedures
- General description of batch certification and releasing procedure
- Role of Authorised Person / Qualified Person in quarantine and release of finished products and in assessment of compliance with the Marketing Authorisation
- The arrangements between Authorised Persons / Qualified Persons when several Authorised Persons / Qualified Persons are involved
- Statement on whether the control strategy employs Process Analytical Technology (PAT) and/or Real Time Release or Parametric Release
- Management of suppliers and contractors
- A brief summary of the establishment/knowledge of supply chain and the external audit program
- Brief description of the qualification system of contractors, manufacturers of active pharmaceutical ingredients (API) and other critical materials suppliers
- Measures taken to ensure that products manufactured are compliant with TSE (Transmitting animal spongiform encephalopathy) guidelines
- Measures adopted where counterfeit/falsified products, bulk products (i.e. unpacked tablets), active pharmaceutical ingredients or excipients are suspected or identified
- Use of outside scientific, analytical or other technical assistance in relation to manufacture and analysis
- List of contract manufacturers and laboratories including the addresses and contact information and flow charts of supply-chains for outsourced manufacturing and Quality Control activities; e.g. sterilisation of primary packaging material for aseptic processes, testing of starting raw materials etc, should be presented in Appendix 4
- Brief overview of the responsibility sharing between the contract giver and acceptor with respect to compliance with the Marketing Authorisation (where not included under 2.2)
- Quality Risk Management (QRM)
- Brief description of QRM methodologies used by the manufacturer
- Scope and focus of QRM including brief description of any activities which are performed at corporate level, and those which are performed locally. Any application of the QRM system to assess continuity of supply should be mentioned
- Product Quality Reviews
- Brief description of methodologies used
- The quality management system of the manufacturer
- Personnel
- Organisation chart showing the arrangements for quality management, production and quality control positions/titles in Appendix 5, including senior management and Authorised Person(s) / Qualified Person(s)
- Qualifications, experience and responsibilities of key personnel
- Number of employees engaged in the quality management, production, quality control, storage and distribution respectively
- Outline of arrangements for basic and in-service training
- Health requirements for personnel engaged in production
- Premises and Equipment
- Premises
- Short description of plant; the location of the site and immediate environment adjacent to manufacturer
- Size including floor area of premises, and list of buildings. If the production for different markets, i.e. for local, EU, USA, etc. takes place in different buildings on the site, the buildings should be listed with destined markets identified (if not identified under 1.1)
- Simple plan or description of manufacturing areas with indication of scale (architectural or engineering drawings are not required)
- Nature of construction and finishes
- Lay outs and flow charts of the production areas (in Appendix 6) showing the room classification and pressure differentials between adjoining areas and indicating the production activities (i.e. compounding, filling, storage, packaging, etc.) in the rooms
- Lay-outs of warehouses and storage areas, with special areas for the storage and handling of highly toxic, hazardous and sensitizing materials indicated, if applicable
- Brief description of specific storage conditions if applicable, but not indicated on the lay-outs
- Brief description of heating, ventilation and air conditioning (HVAC) systems
- Principles for defining the air supply, temperature, humidity, pressure differentials and air change rates, policy of air recirculation (%).
- Brief description of water systems
- Quality references of water produced
- Schematic drawings of the systems in Appendix 7
- Brief description of other relevant utilities, such as steam, compressed air, nitrogen, etc.
- Equipment
- Listing of major production and control laboratory equipment with critical pieces of equipment identified should be provided in Appendix 8.
- Cleaning and sanitation
- Brief description of cleaning and sanitation methods of product contact surfaces (i.e. manual cleaning, automatic Clean-in-Place, etc).
- GMP critical computerised systems
- Description of GMP critical computerised systems (excluding equipment specific Programmable Logic Controllers (PLCs).
- Premises
- Documentation
- Description of documentation system (i.e. electronic, manual)
- When documents and records are stored or archived off-site (including pharmacovigilance data, when applicable): List of types of documents/records, Name and address of storage site and an estimate of time required retrieving documents from the off-site archive.
- Production
- Type of products (References to Appendix 1 or 2 can be made)
- Type of products manufactured including
- list of dosage forms of both human and veterinary products which are manufactured on the site
- list of dosage forms of investigational medicinal products (IMP) manufactured for any clinical trials on the site, and when different from the commercial manufacturing, information of production areas and personnel
- Toxic or hazardous substances handled (e.g. with high pharmacological activity and/or with sensitising properties)
- Product types manufactured in a dedicated facility or on a campaign basis, if applicable
- Process Analytical Technology (PAT) applications, if applicable: general statement of the relevant technology, and associated computerized systems
- Process validation
- Brief description of general policy for process validation
- Policy for reprocessing or reworking
- Material management and warehousing
- Arrangements for the handling of starting materials, packaging materials, bulk and finished products including sampling, quarantine, release and storage;
- Arrangements for the handling of rejected materials and products.
- Type of products (References to Appendix 1 or 2 can be made)
- Quality Control (QC)
- Description of the Quality Control activities carried out on the site in terms of physical, chemical, and microbiological and biological testing.
- Distribution, Complaints, Product Defects and Recalls
- Distribution (to the part under the responsibility of the manufacturer)
- Types (wholesale licence holders, manufacturing licence holders, etc) and locations (countries or regional economic areas) of the companies to which the products are shipped from the site
- Description of the system used to verify that each customer / recipient is legally entitled to receive medicinal products from the manufacturer
- Brief description of the system to ensure appropriate environmental conditions during transit, e.g. temperature monitoring/ control
- Arrangements for product distribution and methods by which product traceability is maintained
- Measures taken to prevent manufacturers’ products to fall in the illegal supply chain
- Complaints, product defects and recalls
- Brief description of the system for handling complaints, product defect and recalls.
- Distribution (to the part under the responsibility of the manufacturer)
- Self Inspections
- Short description of the self inspection system with focus on criteria used for selection of the areas to be covered during planned inspections, practical arrangements and follow-up activities.
Appendices
Appendix 1 | Copy of valid manufacturing authorisation |
Appendix 2 | List of dosage forms manufactured including the INN-names or common name (as available) of active pharmaceutical ingredients (API) used |
Appendix 3 | Copy of valid GMP Certificate |
Appendix 4 | List of contract manufacturers and laboratories including the addresses and contact information, and flow-charts of the supply chains for these outsourced activities |
Appendix 5 | Organisational charts |
Appendix 6 | Lay outs of production areas including material and personnel flows, general flow charts of manufacturing processes of each product type (dosage form) |
Appendix 7 | Schematic drawings of water systems |
Appendix 8 | List of major production and laboratory equipment |
References :
- Content of a site master file; Forty-fifth report of the WHO Expert Committee on Pharmaceutical Preparations, Geneva, 18 – 12 October 2010 (WHO Technical Report Series 961)
- Explanatory notes for pharmaceutical manufacturers on the preparation of a site master file; PE 008 – 4, 1 January 2011, Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- Site Master File; Third Edition, 2014, National Pharmaceutical Regulatory Agency, Malaysia
Local GMP Inspections
The list of approved local manufactures – Medicines
Name of the Manufacturer | Site Address | Product Range | Dates of Most Recent GMP Inspection |
1).Aithra Pharmaceuticals (Pvt) Ltd | 10/1/E, 1st Lane, Palliyawatta, Hendala Wattala | General – topical semisolids | 7th August 2018 |
2).Astron Ltd | No. 688, Galle Road, Ratmalana | General – oral solids and liquids topical semisolids Penicillin – oral solids, suspensions |
23rd November 2015 |
3).CDDEF Manufacturers & Merchant (Pvt) Ltd | 37, Eluwila, Panadura | Chloroxylenol antiseptic liquid | 17th December 2018 |
4).Celogen Lanka (Pvt) Ltd | Lot No. 7A, BOI Industrial Park, Pallekele, Kandy | General – oral solids | 7th September 2017 |
5).CIC Lifesciences (Pvt) Ltd | 52, Lanka Matha Mawtha, Mahabage, Ragama | General – oral solids (tablets, capsules) | 4th May 2018 |
6).Diyatha Pharmaceutical and Healthcare (Pvt) Ltd, | No.53/A/1, Ganemulla Road, Batagama Noth, Ja-Ela | General – oral liquids | 21st May 2019 |
7).Emergen Life Sciences (Pvt) Ltd | No. 667, Biyagama Road, Pethiyagoda, Kelaniya | General – oral capsules, DPI capsules, nasal spray | 11th October 2018 |
8).Flexus Pharma (Pvt) Ltd | 531, Ihalabiyanwila, Siyambalape | General – topical products | 17th May 2019 |
9).Glaxo Wellcome Ceylon Ltd | 121, Galle Road, Kaldemulla, Moratuwa | General – oral solids, liquids | 1st March 2019 |
10).Himata (Pvt) Ltd | 535/2, Sasanawardhanarama Mawatha, Homagama | Povidone Iodine Solution | 28th May 2019 |
11).Interpharm (Pvt) Ltd | 705/1, Madapatha Rd, Piliyandala | General – oral solids Cephalosporins – oral solids |
5th November 2018 |
12).Gamma Pharmaceuticals (Pvt) Ltd. | 705/1, Madapatha Rd, Piliyandala | General – oral liquids, topical semi solids | 5th November 2018 |
13).Lina Manufacturing (Pvt) Ltd | Flinth Commercial Park, Ranmuthugala, Kadawatha | General – oral tablets, DPI capsules, nasal spray, topical semisolids | 5th October 2019 |
14).Medicom (Pvt) Ltd | Dehiwala | General – oral liquids, topical semisolids and liquids | 18th January 2019 |
15).Morison PLC | 126, Aluthmawatha Road, Colombo 15 | General – tablets, oral solutions, topical lotions | 29th December 2017 |
16).M. W. L. De Silva & Company Ltd | 46, Peiris Mawatha, Kalubowila, Dehiwala | Permethrin Head Lotion | 7th December 2018 |
17).Navesta Pharmaceuticals (Pvt)Ltd | 29/3, Kirimandala Mawatha, Nawala, Rajagiriya | Penicillin – injectable | 22nd July 2019 |
18).State Pharmaceuticals Manufacturing Corporation (SPMC) | No. 11, Sir John Kotelawala Mawatha, Kandawala Estate, Ratmalana | General – oral solids Penicillin – oral solids |
25th September 2018 |
19).Universal Lifeline Ceylon (Pvt) Ltd | 19, Industrial Area, Purana Meerigama, Meerigama |
General – topical semisolids |
28th December 2018 |
The list of approved local manufactures – Medical Devices
Name of the Manufacturer | Site Address | Product Range | Dates of Most Recent GMP Inspection |
1).Ansell Lanka (Pvt) Ltd | Biyagama Export Processing Zone, Biyagama, Malwana | Sterile latex Surgical Gloves and Latex Examination Gloves | 10th July 2017 |
2).Ceyflex Rubber Ltd | Plot 81 A, Horana Export Processing Zone, Boralugoda | Natural rubber latex dental dams | 11th October 2018 |
3).Eco Envi Lanka (Pvt) Ltd | #8, 1st Circle, Attawilluwa, Puttalam | Surgeon Cap, Bouffant Cap and Face Masks | 05th January 2019 |
4).Gas World (Pvt) Ltd | No. 152/2, Mabima Rd, Heiyanthuduwa, Sapugaskanda | Liquid and Gaseous Medical Oxygen and Nitrogen and Medical Compressed Air | 17th May 2017 |
5).Hemas Manufacturing (Pvt) Ltd | Bujjampola, Dankotuwa | Manufacturing of Sanitary napkins and Repacking of Baby diaper | 09th December 2016 |
6).International Cosmetics (Pvt) Lt | No. 30/1, Minuwangoda Rd, Ja- Ela | Sanitary napkins | 24th July 2017 |
7).Kayak Surgi Pharma (Pvt) Ltd | No. 30/1, Minuwangoda Rd, Ja- Ela | Cellulose Wadding and Sterile Aprons | 11th September 2018 |
8).Kuvenitex (Pvt) Ltd | Matugama Industrial Zone, Pahe Kanuwa | Surgical Gauze, Gauze Bandage and Crepe Bandage | 22nd May 2018 |
9).Lalan Rubbers (Pvt) Ltd | Block B, Biyagama Export Processing Zone, Biyagama, Malwana | Sterile latex Surgical Gloves and Latex Examination Gloves | 17th May 2019 |
10).M.G. Medical (Pvt) Ltd | 232/8, Kirillawala, Weboda | Hospital Furniture and Medical Consumables | 27th December 2018 |
11).Neon Pharmaceuticals | No. 319, Zone 3, Millennium City, Kotugoda, Ja- Ela | Bicarbonate Concentrate Solution for Haemodialysis | 17th May 2019 |
12).Phoenix Industries Ltd | Industrial Zone (East), Makandura, Gonawila | Toothbrush | 27th November 2017 |
13).Ruchika Meditex (Pvt) Ltd | Palliyapitiya, Dunagaha | Surgical Gauze and Bandages | 13th March 2018 |
14).Shani Medi Tex (Pvt) Ltd | Palliyapitiya, Dunagaha | Non-Sterile woven surgical dressings (Surgical Gauze and Bandages) | 13th March 2018 |
15).Sriyani Ikram Medicals Industries (Pvt) Ltd | No. 57, Ranala Rd, Habarakada | Absorbent cotton gauze roll- (non-sterile) | 19th March 2019 |
16).Sun Industries (Pvt) Ltd | No. 104/11, Grandpass Road, Colombo 14 | Baby Diapers, Sanitary Napkins and Face Masks | 22nd January 2019 |
17).Surtex Industries (Pvt) Ltd | No. 152, Meepe, Padukka | Surgical absorbent gauze & open wove bandage | 21st May 2019 |
18).Vee Pee Enterprises | No. 110, Matugama Rd, Kalutara | Absorbent Cotton Wool, Absorbent Surgical Gauze and Open Woven Bandage | 15th February 2019 |
Foreign GMP inspections in year 2019
Manufacturer | Dates of Inspection | Product Range Inspected | Outcome |
1.Siam Bioscience Co. Ltd, Thailand | 04th -07th February 2019 | Bio therapeutic products | Approved |
2.Hudson Pharma, Karachi, Pakistan | 13th – 15th February 2019 | General – SVPs, eye ear and nasal drops, respiratory solutions, DPI capsules, topical semi-solids and liquids | Approved |
3.Cadila Healthcare Ltd, Plot Surve No. 23, 25/P, 37, 40/P, 42 to 47, India | 25th – 28th February 2019 | Bio therapeutic products | Approved |
4.Heilongjian Province Fulekang Pharmaceutical Co. Ltd, China; | 27th Feb – 2nd March 2019 | Aerosol Inhalers | Approved |
5.Unimax Laboratories, India | 18th -21 March 2019 | General and Beta lactams - oral solid (Tabs and Caps) dosage forms | Approved |
6.Laborate Pharmaceuticals India Limited, Unit-II, India | 22nd – 24th April 2019 | General - Oral and liquid dosage forms and Injections, Eye and Ear preparations, Semisolid external preparations Beta lactams - oral | Approved (except oral liquids) |
7.Baseman Healthcare Inc., India | 28th – 30th May 2019 | General - oral liquids | Not Approved |
8.Naxpar Pharma Pvt. Ltd, India | 19th – 22nd June 2019 | General - oral liquid dosage forms topical semisolid dosage forms and ear drops | Approved (only topical semisolid dosage forms) |
9.VEM ILAC San. Ve Tic A.S, Turkey | 22nd – 25th July 2019 | General dosage forms of oral (Tabs and liquids) and injectable (lyophilized and small volume liquid parenteral), BFS, Semisolid external preparations | Approved |
10.Boya Bio-Pharmaceutical Group Co, China | 05th – 07th August 2019 | Blood products | Approved |
11.Chengdu Hepatum Pharmaceutical, China | 24th – 28th August 2019 | Small volume-Heparin Injection, Normal saline and water for injection, Lyophilized powder for injection and general oral solid dosage forms | Approved |
12.Shandong Kexing Bioproducts Co. Ltd, China; | 30th Aug – 1st Sep. 2019 | Biotherapeutic products | Approved |
13.PT Nepro Jai, Jakarta, Indonesia | 14th – 16th August 2019 | Medical devices - blood tubing bags | Approved |
14.Aristopharma Ltd, Bangladesh | 16th – 19th September 2019 | General oral dosage forms | Approved |
</sliders>
Foreign GMP inspection in year 2015-2018
Manufacturer |
Dates of Inspection | Product Range Inspected | Outcome |
1. Terumo Corporation, Fujihomiya City, Japan | 21st – 22nd December 2016 | Medical devices | Approved |
2. Sante (Pvt) Ltd, A-97, SITE Super Highway, Karachi, Pakistan | 7th – 9th February 2017 | Ophthalmic products | Approved |
3. Virchow Biotech Pvt Ltd, Survey No. 172 Part, Gargillapur, R-R District – 500 043, Telagana, India | 13th – 16th February 2017 |
Biotherapeutic products,General – topical semi-solid preparations |
Approved |
4. East African Overseas, Plot No. 1, Pharmacity, Selaqui, Dehradun, Uttarakhand, India | 21st – 23rd February 2017 | General drugs – oral solids and liquids, injections, ophthalmic products, topical preparations | Approved |
5. Bharath Serums & Vaccines Ltd, Plot No. K-27, Jambivili Village, Anandnagar, Additional MIDC, Ambernath (East), Thane – 421 501, Maharashtra, India | 27th February – 1st March 2017 |
Equine origin sera – Anti snake venom serum, anti-rabies serum, anti-thymocyte globulin |
Approved |
6. CinnGen Co.,3rd Square, Sixth West Street, Simindasht Industrial Area, Karaj, Alborz, Iran | 16th – 17th May 2017 | Biotherapeutic products | Approved |
7. Aryogen Pharmed, No. 140, Corner of Tajbakhsh St, 24thKm. Tehran-Karaj Mkhsous Road, Alborz, Iran | 18th – 20th May 2017 | Biotherapeutic products | Approved |
8. Enicar Pharmaceuticals (Pvt) Ltd, Tarapur, Maharashtra, India | 23rd – 25th May 2017 | General – oral liquids | Approved |
9. McCoy Pharma Pvt Ltd, Plot S-12/13, MIDC, Boisar, Tarapur, Palgar, Maharashtra – 401 506, India |
27th – 29th May 2017
|
General – tablets, soft and hard gelatin capsules |
Approved |
10. Shandong Weigo Medical Polymer Products Co Ltd, China | 7th - 10th July 2017 | Medical devices – blood bags | Approved |
11. Wockhardt Ltd,Biotech Park,H-14/2,MIDC,Waluj,Arungabad,Maharashtra,India | 22nd – 25th August 2017 | Biotherapeutic products | Approved |
12. Centurion Laboratories,G-5,G-6,Industrial Estate,Gorwa,Varodara,Gujarat,India.
Plot No. P-2,Savali Bio-Tech Park,At-Manjusar,Vadodara,Gujarat,India |
13th-15th September 2017 | General – tablets, capsules |
'Gorwa' site to be discontinued when current registration lapse. 'Manjusar' site to be re-inspected within 2 years |
13. Brilliant Lifesciences Pvt. Ltd., Chuval Dangarwa, Katosan – Sadra Road, Detroj, Ahmedabad – 382 120, Gujarat, India | 14th – 15th September 2017 | General – tablets, capsules, oral liquids, external products | Not approved |
14. Merit Organics Ltd,Plot 2104/2/A GIDC Sarigam,-396 155,ValsadGujarat,India | 3rd – 5th October 2017 | General – small volume parenteral, eye drops, ear drops, tablets, capsules, topical preparations | Only solid dosage forms were approved after reviewing CAPA |
15. Zydus Healthcare Ltd, Bhaghey Khola, N.N. No. 10, Majhitar, Rangpo, East-Sikkim – 737 136, India | 11th – 14th December 2017 | General tablets,capsules,Hormones-tablets,gels | Approved |
16. Pinnacle Life Sciences Pvt. Ltd., Manpura, Baddi, Solan, Himachal Pradesh, India | 14th – 16th December 2017 | General – oral solids and liquids, topical ointments | Approved |
17. Aculife Healthcare Pvt. Ltd, Sachana, Viramgam, Ahmedabad, Gujarat – 382 150, India | 21st – 23rd December 2017 | Large volume parenteral (BFS, collapsible bag), small volume parenteral (BFS), eye, ear, nasal drops, general injectable, cephalosporins & penicillin (injections, tablets, capsules, dry syrups) | Approved |
18. Healers Lab Unit II, Himachal Pradesh, India |
12th-14th March 2018 Follow up Inspection:29th-30th October 2018 |
General – oral and topical preparations | Approved after the follow up inspection |
19. Square Formulations Ltd, Momin Nagar, Gorai, Mirzapur, Tangail, Bangladesh | 4th – 6th March 2018 | General – oral dosage forms | Approved |
20. Biocad, Petrovo Dalnee, Krasnogorsky, Moscow Region, Russian Federation | 2nd – 3rd April 2018 | Biotherapeutic products | Approved |
21. Hemarus Therapeutics Ltd, Survey No. 222P, Turkapally, Shameerpet Mandal, Medchal – 500 078, Telangana, India | 13th – 16th June 2018 | Plasma products | Approved |
22. JMS Singapore Pte Ltd, 440, Ang Mo Kio Industrial Park 1, Singapore | 23rd – 25th July 2018 | Medical devices - blood bags | Approved |
23. Apex Laboratories Pvt Ltd, 510, Kunnam, (Via) Thenneri, Sriperumbudur, Kancheepuram - 631 604, Tamil Nadu, India | 6th – 9th August 2018 | General – oral liquids | Approved |
24. Reliance Life Sciences (Pvt) Ltd, Plant 2, Dhirubhai Ambani Lifesciences Centre, R-282, MIDC, Thane Maharashtra, India | 24th – 27th October 2018 | Biotherapeutic products | Approved |
1. Wockhardt Ltd,
<table style="width: 936px; height: 2112px;" class="mtable mhead" border="0">
<tbody>
<tr class="mhead">
<td>
<p><strong>Manufacturer</strong></p>
</td>
<td><strong>Dates of Inspection</strong></td>
<td><strong>Product Range Inspected</strong></td>
<td><strong>Outcome</strong></td>
</tr>
<tr>
<td>1. Terumo Corporation, Fujihomiya City, Japan</td>
<td>21st – 22nd December 2016</td>
<td>Medical devices</td>
<td>Approved</td>
</tr>
<tr>
<td>2. Sante (Pvt) Ltd, A-97, SITE Super Highway, Karachi, Pakistan</td>
<td>7th – 9th February 2017</td>
<td>Ophthalmic products</td>
<td>Approved</td>
</tr>
<tr>
<td>3. Virchow Biotech Pvt Ltd, Survey No. 172 Part, Gargillapur, R-R District – 500 043, Telagana, India</td>
<td>13th – 16th February 2017</td>
<td>
<p>Biotherapeutic products,General – topical semi-solid preparations</p>
</td>
<td>Approved</td>
</tr>
<tr>
<td>4. East African Overseas, Plot No. 1, Pharmacity, Selaqui, Dehradun, Uttarakhand, India</td>
<td>21st – 23rd February 2017</td>
<td>General drugs – oral solids and liquids, injections, ophthalmic products, topical preparations</td>
<td>Approved</td>
</tr>
<tr>
<td>5. Bharath Serums & Vaccines Ltd, Plot No. K-27, Jambivili Village, Anandnagar, Additional MIDC, Ambernath (East), Thane – 421 501, Maharashtra, India</td>
<td>27th February – 1st March 2017</td>
<td>
<p>Equine origin sera – Anti snake venom serum, anti-rabies serum, anti-thymocyte globulin<br />Other biological injectable products</p>
</td>
<td>Approved</td>
</tr>
<tr>
<td>6. CinnGen Co.,3rd Square, Sixth West Street, Simindasht Industrial Area, Karaj, Alborz, Iran</td>
<td>16th – 17th May 2017</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
<tr>
<td>7. Aryogen Pharmed, No. 140, Corner of Tajbakhsh St, 24thKm. Tehran-Karaj Mkhsous Road, Alborz, Iran</td>
<td>18th – 20th May 2017</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
<tr>
<td>8. Enicar Pharmaceuticals (Pvt) Ltd, Tarapur, Maharashtra, India</td>
<td>23rd – 25th May 2017</td>
<td>General – oral liquids</td>
<td>Approved</td>
</tr>
<tr>
<td>9. McCoy Pharma Pvt Ltd, Plot S-12/13, MIDC, Boisar, Tarapur, Palgar, Maharashtra – 401 506, India</td>
<td>
<p> </p>
<p style="text-align: justify;">27<sup>th</sup> – 29<sup>th</sup> May 2017</p>
<p> </p>
</td>
<td><span style="background-color: #f7f6f5;">General – tablets, soft and hard gelatin capsules</span></td>
<td>
<p>Approved</p>
</td>
</tr>
<tr>
<td>10. Shandong Weigo Medical Polymer Products Co Ltd, China</td>
<td>7th - 10th July 2017</td>
<td>Medical devices – blood bags</td>
<td>Approved</td>
</tr>
<tr>
<td>11. Wockhardt Ltd,Biotech Park,H-14/2,MIDC,Waluj,Arungabad,Maharashtra,India</td>
<td>22nd – 25th August 2017</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
<tr>
<td>
<p>12. Centurion Laboratories,G-5,G-6,Industrial Estate,Gorwa,Varodara,Gujarat,India.</p>
<p> </p>
<p>Plot No. P-2,Savali Bio-Tech Park,At-Manjusar,Vadodara,Gujarat,India</p>
</td>
<td><span style="line-height: 106%; font-size: 10pt;"><span face="Calibri, sans-serif" style="font-family: Calibri, sans-serif;">13th-15th September 2017</span></span></td>
<td>General – tablets, capsules</td>
<td>
<p>'Gorwa' site to be discontinued when current registration lapse. </p>
<p>'Manjusar' site to be re-inspected within 2 years</p>
</td>
</tr>
<tr>
<td>13. Brilliant Lifesciences Pvt. Ltd., Chuval Dangarwa, Katosan – Sadra Road, Detroj, Ahmedabad – 382 120, Gujarat, India</td>
<td>14th – 15th September 2017</td>
<td>General – tablets, capsules, oral liquids, external products</td>
<td>Not approved</td>
</tr>
<tr>
<td>14. Merit Organics Ltd,Plot 2104/2/A GIDC Sarigam,-396 155,ValsadGujarat,India</td>
<td>3rd – 5th October 2017</td>
<td>General – small volume parenteral, eye drops, ear drops, tablets, capsules, topical preparations</td>
<td>Only solid dosage forms were approved after reviewing CAPA</td>
</tr>
<tr>
<td>15. Zydus Healthcare Ltd, Bhaghey Khola, N.N. No. 10, Majhitar, Rangpo, East-Sikkim – 737 136, India</td>
<td>11th – 14th December 2017</td>
<td>General tablets,capsules,Hormones-tablets,gels</td>
<td>Approved</td>
</tr>
<tr>
<td>16. Pinnacle Life Sciences Pvt. Ltd., Manpura, Baddi, Solan, Himachal Pradesh, India</td>
<td>14th – 16th December 2017</td>
<td>General – oral solids and liquids, topical ointments</td>
<td>Approved</td>
</tr>
<tr>
<td>17. Aculife Healthcare Pvt. Ltd, Sachana, Viramgam, Ahmedabad, Gujarat – 382 150, India</td>
<td>21st – 23rd December 2017</td>
<td>Large volume parenteral (BFS, collapsible bag), small volume parenteral (BFS), eye, ear, nasal drops, general injectable, cephalosporins & penicillin (injections, tablets, capsules, dry syrups)</td>
<td>Approved</td>
</tr>
<tr>
<td>18. Healers Lab Unit II, Himachal Pradesh, India</td>
<td>
<p>12th-14th March 2018</p>
<p>Follow up Inspection:29th-30th October 2018</p>
</td>
<td>General – oral and topical preparations </td>
<td>Approved after the follow up inspection</td>
</tr>
<tr>
<td>19. Square Formulations Ltd, Momin Nagar, Gorai, Mirzapur, Tangail, Bangladesh</td>
<td>4th – 6th March 2018</td>
<td>General – oral dosage forms</td>
<td>Approved</td>
</tr>
<tr>
<td>20. Biocad, Petrovo Dalnee, Krasnogorsky, Moscow Region, Russian Federation</td>
<td>2nd – 3rd April 2018</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
<tr>
<td>21. Hemarus Therapeutics Ltd, Survey No. 222P, Turkapally, Shameerpet Mandal, Medchal – 500 078, Telangana, India</td>
<td>13th – 16th June 2018</td>
<td>Plasma products</td>
<td>Approved</td>
</tr>
<tr>
<td>22. JMS Singapore Pte Ltd, 440, Ang Mo Kio Industrial Park 1, Singapore</td>
<td>23rd – 25th July 2018</td>
<td>Medical devices - blood bags</td>
<td>Approved</td>
</tr>
<tr>
<td>23. Apex Laboratories Pvt Ltd, 510, Kunnam, (Via) Thenneri, Sriperumbudur, Kancheepuram - 631 604, Tamil Nadu, India</td>
<td>6th – 9th August 2018</td>
<td>General – oral liquids</td>
<td>Approved</td>
</tr>
<tr>
<td>24. Reliance Life Sciences (Pvt) Ltd, Plant 2, Dhirubhai Ambani Lifesciences Centre, R-282, MIDC, Thane Maharashtra, India</td>
<td>24th – 27th October 2018</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
</tbody>
</table>
<p>
<p><span style="font-size: 14pt;"><strong>The list of approved local manufactures – Medicines</strong></span></p>
<table class="mtable" style="width: 100%;" border="0">
<tbody>
<tr>
<td><strong>Name of the Manufacturer</strong></td>
<td><strong>Site Address</strong></td>
<td><strong>Product Range</strong></td>
<td><strong>Dates of Most Recent GMP Inspection</strong></td>
</tr>
<tr>
<td>1).Aithra Pharmaceuticals (Pvt) Ltd</td>
<td>10/1/E, 1st Lane, Palliyawatta, Hendala Wattala</td>
<td>General – topical semisolids</td>
<td>7th August 2018</td>
</tr>
<tr>
<td>2).Astron Ltd</td>
<td>No. 688, Galle Road, Ratmalana</td>
<td>General – oral solids and liquids<br /> topical semisolids<br />Penicillin – oral solids, suspensions<br /><br data-mce-bogus="1" /></td>
<td>23rd November 2015</td>
</tr>
<tr>
<td>3).CDDEF Manufacturers & Merchant (Pvt) Ltd</td>
<td>37, Eluwila, Panadura</td>
<td>Chloroxylenol antiseptic liquid</td>
<td>17th December 2018</td>
</tr>
<tr>
<td>4).Celogen Lanka (Pvt) Ltd</td>
<td>Lot No. 7A, BOI Industrial Park, Pallekele, Kandy</td>
<td>General – oral solids</td>
<td>7th September 2017</td>
</tr>
<tr>
<td>5).CIC Lifesciences (Pvt) Ltd</td>
<td>52, Lanka Matha Mawtha, Mahabage, Ragama</td>
<td>General – oral solids (tablets, capsules)</td>
<td>4th May 2018</td>
</tr>
<tr>
<td>6).Diyatha Pharmaceutical and Healthcare (Pvt) Ltd,</td>
<td>No.53/A/1, Ganemulla Road, Batagama Noth, Ja-Ela</td>
<td>General – oral liquids</td>
<td>21st May 2019</td>
</tr>
<tr>
<td>7).Emergen Life Sciences (Pvt) Ltd</td>
<td>No. 667, Biyagama Road, Pethiyagoda, Kelaniya</td>
<td>General – oral capsules, DPI capsules, nasal spray</td>
<td>11th October 2018</td>
</tr>
<tr>
<td>8).Flexus Pharma (Pvt) Ltd</td>
<td>531, Ihalabiyanwila, Siyambalape</td>
<td>General – topical products</td>
<td>17th May 2019</td>
</tr>
<tr>
<td>9).Glaxo Wellcome Ceylon Ltd</td>
<td>121, Galle Road, Kaldemulla, Moratuwa</td>
<td>General – oral solids, liquids</td>
<td>1st March 2019</td>
</tr>
<tr>
<td>10).Himata (Pvt) Ltd</td>
<td>535/2, Sasanawardhanarama Mawatha, Homagama</td>
<td>Povidone Iodine Solution</td>
<td>28th May 2019</td>
</tr>
<tr>
<td>11).Interpharm (Pvt) Ltd</td>
<td>705/1, Madapatha Rd, Piliyandala</td>
<td>General – oral solids<br />Cephalosporins – oral solids<br /><br data-mce-bogus="1" /></td>
<td>5th November 2018</td>
</tr>
<tr>
<td>12).Gamma Pharmaceuticals (Pvt) Ltd.</td>
<td>705/1, Madapatha Rd, Piliyandala</td>
<td>General – oral liquids, topical semi solids</td>
<td>5th November 2018</td>
</tr>
<tr>
<td>13).Lina Manufacturing (Pvt) Ltd</td>
<td>Flinth Commercial Park, Ranmuthugala, Kadawatha</td>
<td>General – oral tablets, DPI capsules, nasal spray, topical semisolids</td>
<td>5th October 2019</td>
</tr>
<tr>
<td>14).Medicom (Pvt) Ltd</td>
<td>Dehiwala</td>
<td>General – oral liquids, topical semisolids and liquids</td>
<td>18th January 2019</td>
</tr>
<tr>
<td>15).Morison PLC</td>
<td>126, Aluthmawatha Road, Colombo 15</td>
<td>General – tablets, oral solutions, topical lotions</td>
<td>29th December 2017</td>
</tr>
<tr>
<td>16).M. W. L. De Silva & Company Ltd</td>
<td>46, Peiris Mawatha, Kalubowila, Dehiwala</td>
<td>Permethrin Head Lotion</td>
<td>7th December 2018</td>
</tr>
<tr>
<td>17).Navesta Pharmaceuticals (Pvt)Ltd</td>
<td>29/3, Kirimandala Mawatha, Nawala, Rajagiriya</td>
<td>Penicillin – injectable</td>
<td>22nd July 2019</td>
</tr>
<tr>
<td>18).State Pharmaceuticals Manufacturing Corporation (SPMC)</td>
<td>No. 11, Sir John Kotelawala Mawatha, Kandawala Estate, Ratmalana</td>
<td>General – oral solids<br />Penicillin – oral solids</td>
<td>25th September 2018</td>
</tr>
<tr>
<td>19).Universal Lifeline Ceylon (Pvt) Ltd</td>
<td>19, Industrial Area, Purana Meerigama, Meerigama<br /><br data-mce-bogus="1" /></td>
<td>General – topical semisolids<br /><br data-mce-bogus="1" /></td>
<td>28th December 2018</td>
</tr>
</tbody>
</table>
<p><strong><span style="font-size: 14pt;">The list of approved local manufactures – Medical Devices</span></strong> <br /><br /></p>
<table class="mtable" style="width: 100%;" border="0">
<tbody>
<tr>
<td><strong>Name of the Manufacturer</strong></td>
<td><strong>Site Address</strong></td>
<td><strong>Product Range</strong></td>
<td><strong>Dates of Most Recent GMP Inspection</strong></td>
</tr>
<tr>
<td>1).Ansell Lanka (Pvt) Ltd</td>
<td>Biyagama Export Processing Zone, Biyagama, Malwana</td>
<td>Sterile latex Surgical Gloves and Latex Examination Gloves</td>
<td>10th July 2017</td>
</tr>
<tr>
<td>2).Ceyflex Rubber Ltd</td>
<td>Plot 81 A, Horana Export Processing Zone, Boralugoda</td>
<td>Natural rubber latex dental dams</td>
<td>11th October 2018</td>
</tr>
<tr>
<td>3).Eco Envi Lanka (Pvt) Ltd</td>
<td>#8, 1st Circle, Attawilluwa, Puttalam</td>
<td>Surgeon Cap, Bouffant Cap and Face Masks</td>
<td>05th January 2019</td>
</tr>
<tr>
<td>4).Gas World (Pvt) Ltd</td>
<td>No. 152/2, Mabima Rd, Heiyanthuduwa, Sapugaskanda</td>
<td>Liquid and Gaseous Medical Oxygen and Nitrogen and Medical Compressed Air</td>
<td>17th May 2017</td>
</tr>
<tr>
<td>5).Hemas Manufacturing (Pvt) Ltd</td>
<td>Bujjampola, Dankotuwa</td>
<td>Manufacturing of Sanitary napkins and Repacking of Baby diaper</td>
<td>09th December 2016</td>
</tr>
<tr>
<td>6).International Cosmetics (Pvt) Lt</td>
<td>No. 30/1, Minuwangoda Rd, Ja- Ela</td>
<td>Sanitary napkins</td>
<td>24th July 2017</td>
</tr>
<tr>
<td>7).Kayak Surgi Pharma (Pvt) Ltd</td>
<td>No. 30/1, Minuwangoda Rd, Ja- Ela</td>
<td>Cellulose Wadding and Sterile Aprons</td>
<td>11th September 2018</td>
</tr>
<tr>
<td>8).Kuvenitex (Pvt) Ltd</td>
<td>Matugama Industrial Zone, Pahe Kanuwa</td>
<td>Surgical Gauze, Gauze Bandage and Crepe Bandage</td>
<td>22nd May 2018</td>
</tr>
<tr>
<td>9).Lalan Rubbers (Pvt) Ltd</td>
<td>Block B, Biyagama Export Processing Zone, Biyagama, Malwana</td>
<td>Sterile latex Surgical Gloves and Latex Examination Gloves</td>
<td>17th May 2019</td>
</tr>
<tr>
<td>10).M.G. Medical (Pvt) Ltd</td>
<td>232/8, Kirillawala, Weboda</td>
<td>Hospital Furniture and Medical Consumables</td>
<td>27th December 2018</td>
</tr>
<tr>
<td>11).Neon Pharmaceuticals</td>
<td>No. 319, Zone 3, Millennium City, Kotugoda, Ja- Ela</td>
<td>Bicarbonate Concentrate Solution for Haemodialysis</td>
<td>17th May 2019</td>
</tr>
<tr>
<td>12).Phoenix Industries Ltd</td>
<td>Industrial Zone (East), Makandura, Gonawila</td>
<td>Toothbrush</td>
<td>27th November 2017</td>
</tr>
<tr>
<td>13).Ruchika Meditex (Pvt) Ltd</td>
<td>Palliyapitiya, Dunagaha</td>
<td>Surgical Gauze and Bandages</td>
<td>13th March 2018</td>
</tr>
<tr>
<td>14).Shani Medi Tex (Pvt) Ltd</td>
<td>Palliyapitiya, Dunagaha</td>
<td>Non-Sterile woven surgical dressings (Surgical Gauze and Bandages)</td>
<td>13th March 2018</td>
</tr>
<tr>
<td>15).Sriyani Ikram Medicals Industries (Pvt) Ltd</td>
<td>No. 57, Ranala Rd, Habarakada</td>
<td>Absorbent cotton gauze roll- (non-sterile)</td>
<td>19th March 2019</td>
</tr>
<tr>
<td>16).Sun Industries (Pvt) Ltd</td>
<td>No. 104/11, Grandpass Road, Colombo 14</td>
<td>Baby Diapers, Sanitary Napkins and Face Masks</td>
<td>22nd January 2019</td>
</tr>
<tr>
<td>17).Surtex Industries (Pvt) Ltd</td>
<td>No. 152, Meepe, Padukka</td>
<td>Surgical absorbent gauze & open wove bandage</td>
<td>21st May 2019</td>
</tr>
<tr>
<td>18).Vee Pee Enterprises</td>
<td>No. 110, Matugama Rd, Kalutara</td>
<td>Absorbent Cotton Wool, Absorbent Surgical Gauze and Open Woven Bandage</td>
<td>15th February 2019</td>
</tr>
</tbody>
</table>
<p></p>
<p>
<tbody>
<tr class="mhead">
<td>
<p><strong>Manufacturer</strong></p>
</td>
<td><strong>Dates of Inspection</strong></td>
<td><strong>Product Range Inspected</strong></td>
<td><strong>Outcome</strong></td>
</tr>
<tr>
<td>1. Terumo Corporation, Fujihomiya City, Japan</td>
<td>21st – 22nd December 2016</td>
<td>Medical devices</td>
<td>Approved</td>
</tr>
<tr>
<td>2. Sante (Pvt) Ltd, A-97, SITE Super Highway, Karachi, Pakistan</td>
<td>7th – 9th February 2017</td>
<td>Ophthalmic products</td>
<td>Approved</td>
</tr>
<tr>
<td>3. Virchow Biotech Pvt Ltd, Survey No. 172 Part, Gargillapur, R-R District – 500 043, Telagana, India</td>
<td>13th – 16th February 2017</td>
<td>
<p>Biotherapeutic products,General – topical semi-solid preparations</p>
</td>
<td>Approved</td>
</tr>
<tr>
<td>4. East African Overseas, Plot No. 1, Pharmacity, Selaqui, Dehradun, Uttarakhand, India</td>
<td>21st – 23rd February 2017</td>
<td>General drugs – oral solids and liquids, injections, ophthalmic products, topical preparations</td>
<td>Approved</td>
</tr>
<tr>
<td>5. Bharath Serums & Vaccines Ltd, Plot No. K-27, Jambivili Village, Anandnagar, Additional MIDC, Ambernath (East), Thane – 421 501, Maharashtra, India</td>
<td>27th February – 1st March 2017</td>
<td>
<p>Equine origin sera – Anti snake venom serum, anti-rabies serum, anti-thymocyte globulin<br />Other biological injectable products</p>
</td>
<td>Approved</td>
</tr>
<tr>
<td>6. CinnGen Co.,3rd Square, Sixth West Street, Simindasht Industrial Area, Karaj, Alborz, Iran</td>
<td>16th – 17th May 2017</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
<tr>
<td>7. Aryogen Pharmed, No. 140, Corner of Tajbakhsh St, 24thKm. Tehran-Karaj Mkhsous Road, Alborz, Iran</td>
<td>18th – 20th May 2017</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
<tr>
<td>8. Enicar Pharmaceuticals (Pvt) Ltd, Tarapur, Maharashtra, India</td>
<td>23rd – 25th May 2017</td>
<td>General – oral liquids</td>
<td>Approved</td>
</tr>
<tr>
<td>9. McCoy Pharma Pvt Ltd, Plot S-12/13, MIDC, Boisar, Tarapur, Palgar, Maharashtra – 401 506, India</td>
<td>
<p> </p>
<p style="text-align: justify;">27<sup>th</sup> – 29<sup>th</sup> May 2017</p>
<p> </p>
</td>
<td><span style="background-color: #f7f6f5;">General – tablets, soft and hard gelatin capsules</span></td>
<td>
<p>Approved</p>
</td>
</tr>
<tr>
<td>10. Shandong Weigo Medical Polymer Products Co Ltd, China</td>
<td>7th - 10th July 2017</td>
<td>Medical devices – blood bags</td>
<td>Approved</td>
</tr>
<tr>
<td>11. Wockhardt Ltd,Biotech Park,H-14/2,MIDC,Waluj,Arungabad,Maharashtra,India</td>
<td>22nd – 25th August 2017</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
<tr>
<td>
<p>12. Centurion Laboratories,G-5,G-6,Industrial Estate,Gorwa,Varodara,Gujarat,India.</p>
<p> </p>
<p>Plot No. P-2,Savali Bio-Tech Park,At-Manjusar,Vadodara,Gujarat,India</p>
</td>
<td><span style="line-height: 106%; font-size: 10pt;"><span face="Calibri, sans-serif" style="font-family: Calibri, sans-serif;">13th-15th September 2017</span></span></td>
<td>General – tablets, capsules</td>
<td>
<p>'Gorwa' site to be discontinued when current registration lapse. </p>
<p>'Manjusar' site to be re-inspected within 2 years</p>
</td>
</tr>
<tr>
<td>13. Brilliant Lifesciences Pvt. Ltd., Chuval Dangarwa, Katosan – Sadra Road, Detroj, Ahmedabad – 382 120, Gujarat, India</td>
<td>14th – 15th September 2017</td>
<td>General – tablets, capsules, oral liquids, external products</td>
<td>Not approved</td>
</tr>
<tr>
<td>14. Merit Organics Ltd,Plot 2104/2/A GIDC Sarigam,-396 155,ValsadGujarat,India</td>
<td>3rd – 5th October 2017</td>
<td>General – small volume parenteral, eye drops, ear drops, tablets, capsules, topical preparations</td>
<td>Only solid dosage forms were approved after reviewing CAPA</td>
</tr>
<tr>
<td>15. Zydus Healthcare Ltd, Bhaghey Khola, N.N. No. 10, Majhitar, Rangpo, East-Sikkim – 737 136, India</td>
<td>11th – 14th December 2017</td>
<td>General tablets,capsules,Hormones-tablets,gels</td>
<td>Approved</td>
</tr>
<tr>
<td>16. Pinnacle Life Sciences Pvt. Ltd., Manpura, Baddi, Solan, Himachal Pradesh, India</td>
<td>14th – 16th December 2017</td>
<td>General – oral solids and liquids, topical ointments</td>
<td>Approved</td>
</tr>
<tr>
<td>17. Aculife Healthcare Pvt. Ltd, Sachana, Viramgam, Ahmedabad, Gujarat – 382 150, India</td>
<td>21st – 23rd December 2017</td>
<td>Large volume parenteral (BFS, collapsible bag), small volume parenteral (BFS), eye, ear, nasal drops, general injectable, cephalosporins & penicillin (injections, tablets, capsules, dry syrups)</td>
<td>Approved</td>
</tr>
<tr>
<td>18. Healers Lab Unit II, Himachal Pradesh, India</td>
<td>
<p>12th-14th March 2018</p>
<p>Follow up Inspection:29th-30th October 2018</p>
</td>
<td>General – oral and topical preparations </td>
<td>Approved after the follow up inspection</td>
</tr>
<tr>
<td>19. Square Formulations Ltd, Momin Nagar, Gorai, Mirzapur, Tangail, Bangladesh</td>
<td>4th – 6th March 2018</td>
<td>General – oral dosage forms</td>
<td>Approved</td>
</tr>
<tr>
<td>20. Biocad, Petrovo Dalnee, Krasnogorsky, Moscow Region, Russian Federation</td>
<td>2nd – 3rd April 2018</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
<tr>
<td>21. Hemarus Therapeutics Ltd, Survey No. 222P, Turkapally, Shameerpet Mandal, Medchal – 500 078, Telangana, India</td>
<td>13th – 16th June 2018</td>
<td>Plasma products</td>
<td>Approved</td>
</tr>
<tr>
<td>22. JMS Singapore Pte Ltd, 440, Ang Mo Kio Industrial Park 1, Singapore</td>
<td>23rd – 25th July 2018</td>
<td>Medical devices - blood bags</td>
<td>Approved</td>
</tr>
<tr>
<td>23. Apex Laboratories Pvt Ltd, 510, Kunnam, (Via) Thenneri, Sriperumbudur, Kancheepuram - 631 604, Tamil Nadu, India</td>
<td>6th – 9th August 2018</td>
<td>General – oral liquids</td>
<td>Approved</td>
</tr>
<tr>
<td>24. Reliance Life Sciences (Pvt) Ltd, Plant 2, Dhirubhai Ambani Lifesciences Centre, R-282, MIDC, Thane Maharashtra, India</td>
<td>24th – 27th October 2018</td>
<td>Biotherapeutic products</td>
<td>Approved</td>
</tr>
</tbody>
</table>
<p>
Good Manufacturing Practice (GMP) Inspections carried out on Sri Lanka
</p><p><span style="font-size: 14pt;"><strong>The list of approved local manufactures – Medicines</strong></span></p>
<table class="mtable" style="width: 100%;" border="0">
<tbody>
<tr>
<td><strong>Name of the Manufacturer</strong></td>
<td><strong>Site Address</strong></td>
<td><strong>Product Range</strong></td>
<td><strong>Dates of Most Recent GMP Inspection</strong></td>
</tr>
<tr>
<td>1).Aithra Pharmaceuticals (Pvt) Ltd</td>
<td>10/1/E, 1st Lane, Palliyawatta, Hendala Wattala</td>
<td>General – topical semisolids</td>
<td>7th August 2018</td>
</tr>
<tr>
<td>2).Astron Ltd</td>
<td>No. 688, Galle Road, Ratmalana</td>
<td>General – oral solids and liquids<br /> topical semisolids<br />Penicillin – oral solids, suspensions<br /><br data-mce-bogus="1" /></td>
<td>23rd November 2015</td>
</tr>
<tr>
<td>3).CDDEF Manufacturers & Merchant (Pvt) Ltd</td>
<td>37, Eluwila, Panadura</td>
<td>Chloroxylenol antiseptic liquid</td>
<td>17th December 2018</td>
</tr>
<tr>
<td>4).Celogen Lanka (Pvt) Ltd</td>
<td>Lot No. 7A, BOI Industrial Park, Pallekele, Kandy</td>
<td>General – oral solids</td>
<td>7th September 2017</td>
</tr>
<tr>
<td>5).CIC Lifesciences (Pvt) Ltd</td>
<td>52, Lanka Matha Mawtha, Mahabage, Ragama</td>
<td>General – oral solids (tablets, capsules)</td>
<td>4th May 2018</td>
</tr>
<tr>
<td>6).Diyatha Pharmaceutical and Healthcare (Pvt) Ltd,</td>
<td>No.53/A/1, Ganemulla Road, Batagama Noth, Ja-Ela</td>
<td>General – oral liquids</td>
<td>21st May 2019</td>
</tr>
<tr>
<td>7).Emergen Life Sciences (Pvt) Ltd</td>
<td>No. 667, Biyagama Road, Pethiyagoda, Kelaniya</td>
<td>General – oral capsules, DPI capsules, nasal spray</td>
<td>11th October 2018</td>
</tr>
<tr>
<td>8).Flexus Pharma (Pvt) Ltd</td>
<td>531, Ihalabiyanwila, Siyambalape</td>
<td>General – topical products</td>
<td>17th May 2019</td>
</tr>
<tr>
<td>9).Glaxo Wellcome Ceylon Ltd</td>
<td>121, Galle Road, Kaldemulla, Moratuwa</td>
<td>General – oral solids, liquids</td>
<td>1st March 2019</td>
</tr>
<tr>
<td>10).Himata (Pvt) Ltd</td>
<td>535/2, Sasanawardhanarama Mawatha, Homagama</td>
<td>Povidone Iodine Solution</td>
<td>28th May 2019</td>
</tr>
<tr>
<td>11).Interpharm (Pvt) Ltd</td>
<td>705/1, Madapatha Rd, Piliyandala</td>
<td>General – oral solids<br />Cephalosporins – oral solids<br /><br data-mce-bogus="1" /></td>
<td>5th November 2018</td>
</tr>
<tr>
<td>12).Gamma Pharmaceuticals (Pvt) Ltd.</td>
<td>705/1, Madapatha Rd, Piliyandala</td>
<td>General – oral liquids, topical semi solids</td>
<td>5th November 2018</td>
</tr>
<tr>
<td>13).Lina Manufacturing (Pvt) Ltd</td>
<td>Flinth Commercial Park, Ranmuthugala, Kadawatha</td>
<td>General – oral tablets, DPI capsules, nasal spray, topical semisolids</td>
<td>5th October 2019</td>
</tr>
<tr>
<td>14).Medicom (Pvt) Ltd</td>
<td>Dehiwala</td>
<td>General – oral liquids, topical semisolids and liquids</td>
<td>18th January 2019</td>
</tr>
<tr>
<td>15).Morison PLC</td>
<td>126, Aluthmawatha Road, Colombo 15</td>
<td>General – tablets, oral solutions, topical lotions</td>
<td>29th December 2017</td>
</tr>
<tr>
<td>16).M. W. L. De Silva & Company Ltd</td>
<td>46, Peiris Mawatha, Kalubowila, Dehiwala</td>
<td>Permethrin Head Lotion</td>
<td>7th December 2018</td>
</tr>
<tr>
<td>17).Navesta Pharmaceuticals (Pvt)Ltd</td>
<td>29/3, Kirimandala Mawatha, Nawala, Rajagiriya</td>
<td>Penicillin – injectable</td>
<td>22nd July 2019</td>
</tr>
<tr>
<td>18).State Pharmaceuticals Manufacturing Corporation (SPMC)</td>
<td>No. 11, Sir John Kotelawala Mawatha, Kandawala Estate, Ratmalana</td>
<td>General – oral solids<br />Penicillin – oral solids</td>
<td>25th September 2018</td>
</tr>
<tr>
<td>19).Universal Lifeline Ceylon (Pvt) Ltd</td>
<td>19, Industrial Area, Purana Meerigama, Meerigama<br /><br data-mce-bogus="1" /></td>
<td>General – topical semisolids<br /><br data-mce-bogus="1" /></td>
<td>28th December 2018</td>
</tr>
</tbody>
</table>
<p><strong><span style="font-size: 14pt;">The list of approved local manufactures – Medical Devices</span></strong> <br /><br /></p>
<table class="mtable" style="width: 100%;" border="0">
<tbody>
<tr>
<td><strong>Name of the Manufacturer</strong></td>
<td><strong>Site Address</strong></td>
<td><strong>Product Range</strong></td>
<td><strong>Dates of Most Recent GMP Inspection</strong></td>
</tr>
<tr>
<td>1).Ansell Lanka (Pvt) Ltd</td>
<td>Biyagama Export Processing Zone, Biyagama, Malwana</td>
<td>Sterile latex Surgical Gloves and Latex Examination Gloves</td>
<td>10th July 2017</td>
</tr>
<tr>
<td>2).Ceyflex Rubber Ltd</td>
<td>Plot 81 A, Horana Export Processing Zone, Boralugoda</td>
<td>Natural rubber latex dental dams</td>
<td>11th October 2018</td>
</tr>
<tr>
<td>3).Eco Envi Lanka (Pvt) Ltd</td>
<td>#8, 1st Circle, Attawilluwa, Puttalam</td>
<td>Surgeon Cap, Bouffant Cap and Face Masks</td>
<td>05th January 2019</td>
</tr>
<tr>
<td>4).Gas World (Pvt) Ltd</td>
<td>No. 152/2, Mabima Rd, Heiyanthuduwa, Sapugaskanda</td>
<td>Liquid and Gaseous Medical Oxygen and Nitrogen and Medical Compressed Air</td>
<td>17th May 2017</td>
</tr>
<tr>
<td>5).Hemas Manufacturing (Pvt) Ltd</td>
<td>Bujjampola, Dankotuwa</td>
<td>Manufacturing of Sanitary napkins and Repacking of Baby diaper</td>
<td>09th December 2016</td>
</tr>
<tr>
<td>6).International Cosmetics (Pvt) Lt</td>
<td>No. 30/1, Minuwangoda Rd, Ja- Ela</td>
<td>Sanitary napkins</td>
<td>24th July 2017</td>
</tr>
<tr>
<td>7).Kayak Surgi Pharma (Pvt) Ltd</td>
<td>No. 30/1, Minuwangoda Rd, Ja- Ela</td>
<td>Cellulose Wadding and Sterile Aprons</td>
<td>11th September 2018</td>
</tr>
<tr>
<td>8).Kuvenitex (Pvt) Ltd</td>
<td>Matugama Industrial Zone, Pahe Kanuwa</td>
<td>Surgical Gauze, Gauze Bandage and Crepe Bandage</td>
<td>22nd May 2018</td>
</tr>
<tr>
<td>9).Lalan Rubbers (Pvt) Ltd</td>
<td>Block B, Biyagama Export Processing Zone, Biyagama, Malwana</td>
<td>Sterile latex Surgical Gloves and Latex Examination Gloves</td>
<td>17th May 2019</td>
</tr>
<tr>
<td>10).M.G. Medical (Pvt) Ltd</td>
<td>232/8, Kirillawala, Weboda</td>
<td>Hospital Furniture and Medical Consumables</td>
<td>27th December 2018</td>
</tr>
<tr>
<td>11).Neon Pharmaceuticals</td>
<td>No. 319, Zone 3, Millennium City, Kotugoda, Ja- Ela</td>
<td>Bicarbonate Concentrate Solution for Haemodialysis</td>
<td>17th May 2019</td>
</tr>
<tr>
<td>12).Phoenix Industries Ltd</td>
<td>Industrial Zone (East), Makandura, Gonawila</td>
<td>Toothbrush</td>
<td>27th November 2017</td>
</tr>
<tr>
<td>13).Ruchika Meditex (Pvt) Ltd</td>
<td>Palliyapitiya, Dunagaha</td>
<td>Surgical Gauze and Bandages</td>
<td>13th March 2018</td>
</tr>
<tr>
<td>14).Shani Medi Tex (Pvt) Ltd</td>
<td>Palliyapitiya, Dunagaha</td>
<td>Non-Sterile woven surgical dressings (Surgical Gauze and Bandages)</td>
<td>13th March 2018</td>
</tr>
<tr>
<td>15).Sriyani Ikram Medicals Industries (Pvt) Ltd</td>
<td>No. 57, Ranala Rd, Habarakada</td>
<td>Absorbent cotton gauze roll- (non-sterile)</td>
<td>19th March 2019</td>
</tr>
<tr>
<td>16).Sun Industries (Pvt) Ltd</td>
<td>No. 104/11, Grandpass Road, Colombo 14</td>
<td>Baby Diapers, Sanitary Napkins and Face Masks</td>
<td>22nd January 2019</td>
</tr>
<tr>
<td>17).Surtex Industries (Pvt) Ltd</td>
<td>No. 152, Meepe, Padukka</td>
<td>Surgical absorbent gauze & open wove bandage</td>
<td>21st May 2019</td>
</tr>
<tr>
<td>18).Vee Pee Enterprises</td>
<td>No. 110, Matugama Rd, Kalutara</td>
<td>Absorbent Cotton Wool, Absorbent Surgical Gauze and Open Woven Bandage</td>
<td>15th February 2019</td>
</tr>
</tbody>
</table>
<p></p>
<p>