Unichem Roha Facility successfully passes FDA test

▴ Unichem Roha Facility successfully passes FDA test
Unichem obtains clearance for Roha facility

The United States Food and Drug Administration conducted inspection at the Company's Active Pharmaceutical Ingredients (APls) manufacturing unit located at Roha from 17th to 21 st February, 2020.The inspection was a routine cGMP surveillance and successfully concluded without any FDA form 483 issued.

Unichem Laboratories was founded in 1944 by Late Mr. Amrut Mody, a pioneer in the Indian pharmaceuticals business. With a rich tradition of unwavering quality and reliability, Unichem brings together a unique blend of modern, value-added research and deep knowledge of the Indian pharmaceuticals industry.The Active Pharmaceutical Ingredient (API) portfolio is a core Strategic Business Unit. High quality standards and transparency in the manufacturing process make Unichem one of the most quality driven API manufacturing companies in the world.

Unichem offers a broad portfolio of APIs across various therapeutic areas. A strategic focus on new and complex APIs has led to more than 70 USDMFs (Drug Master Files) and 30 CEPs (Certificates of Suitability) being filed. Three state-of-the-art manufacturing sites across India provide a collective capacity of almost 600 KL.

Tags : #Unichem #Rohafactory #Approval #Usfda

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