Matrix Laboratories Ltd - Unit 8
- PharmAssess™ GMP Audit
About Matrix Laboratories Ltd
Matrix Laboratories has manufacturing facilities at four locations in and around Hyderabad and Visakhapatnam, India, manufacturing a wide range of Active Pharmaceutical Ingredients. The company's Solid Oral Dosage Forms facility is located near Nashik, about 150 km from Mumbai. All the manufacturing facilities in India have been designed to meet the requirements of Drug Regulatory Agencies. All our facilities are US-FDA approved. The facilities also have ISO 9000, ISO 14000 Certifications.
The Matrix Laboratories Ltd unit 8 site at Vizianagaram is located 55km north of Vizag, midway between Chennai and Kolkata. The journey time is approximately 1hr and for virtually all the journey, the road is a new dual carriageway, NH 5.
Access to the site is security controlled. There is a painted masonry perimeter wall topped with a chain-link fence and barbed wire.
About the Audit
The audit of the Matrix Laboratories Limited Unit 8 site was performed on 4 - 5 October 2007. The Report includes photographs and is 36 pages long, excluding appendices. Including appendices the Report is 59 pages long.
The Audit Report provides information on the site facilities and covers a wide range of materials, including; Cytosine Menthyl Ester, Cyclo Hexyl Ester, Propafenone Hydrochloride USP/Ph.Eur, DL-Naproxen, Abacavir Sulfate, Nelfinavir Mesylate, Allopurinol USP/BP/IP, Indinavir Sulfate USP/IP, Lamivudine USP/IP, Tiaprofenic Acid EP, Trazadone Hydrochloride USP/BP, Sildenafil Citrate, Naproxen USP/BP/IP, Naproxen Sodium USP, Efavirenz, Baclofen USP/BP/EP, Lisinopril Intermediate, Nabumetone USP/BP, Ritonavir, Tenofovir Disoproxil Fumarate, Memantine Hydrochloride, Lopinavir + Ritonavir premix, Atazanavir Sulfate, Alendronate Sodium USP, Residronate Sodium, Zidovudine USP/EP/IP, Nabumetone USP/BP.
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