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.