With formulations forming the core of Unichem’s business, the company also manufactures active pharmaceutical ingredients (APIs or bulk actives). In addition, it has several pharma products that address relevant and growing therapeutic areas like gastroenterology, cardiology, diabetology, psychiatry, neurology, anti-bacterials, anti-infectives and pain management among others.
Unichem is headquartered in Mumbai, India, and has six drug manufacturing locations across the country with several of the company’s facilities being accredited by US FDA, ISO, UK MHRA (earlier MCA), MCC (South Africa), WHO (Geneva) and TGA (Australia).
The company announced that it has received ANDA approval from the United States Food and Drug Administration (USFDA) for Donepezil Hydrochloride Tablets USP.
Donepezil Hydrochloride Tablets USP 5mg and 10mg are therapeutically equivalent to Aricept Tablets, 5mg and 10mg of Eisai, Inc. (USA).
Unichem Laboratories Limited now has total of 21 molecules approved from USFDA.
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