Malladi
- PharmAssess™ GMP Audit
About Malladi Inc.
Malladi Drugs and Pharmaceuticals Ltd was set up in 1980 as the successor to the original organisation founded in 1977. It is one of the largest producers of Ephedrine and Pseudoephedrine in the World. The company’s main market is the United States of America but it is also has major customers in Europe, the Middle East, Latin America and Southeast Asia.
The company operates a number of sites in India and one (Novus Fine Chemicals) in the USA. The Corporate Head Office and the Research and Development laboratories are located in city of Chennai. The factory that is subject of this Audit Report, Unit 3, is located in the village of Ranipet.
About the Audit
The Malladi Drugs and Pharmaceuticals Limited Unit 3 manufacturing site at Ranipet, Tamil Nadu, India was audited between 20th and 21st June 2007.
The Report includes photographs and is 49 pages long, excluding appendices. Including appendices the Report is 134 pages long.
The Audit Report provides information on the site facilities and covers the materials: Pseudoephedrine Hydrochloride, Pseudoephedrine Suplphate, Phenylephrine Hydrochloride, Phenylephrine Base, Phenylephrine Bitartrate, Triprolidine Hydrochloride, along with a comprehensive review of their quality systems.
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