Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection

Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations

The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules

Granules now have a total of 53 ANDA approvals from USFDA

Granules Pharmaceuticals clears USFDA audit

This is the sixth successful USFDA audit for this facility

Granules Pharmaceuticals concludes USFDA audit with three minor observations

The audit is a PAI for two of its product applications filed from this facility

We plan to invest Rs. 1,000 Cr in the next 3 to 4 years : Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals

India is dependent upon China and other countries for a lot of Key Starting Materials (KSM) for their bulk drug needs.

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older

Granules India FDA approval for ADHD treatment

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA

Granules India receives ANDA approval for Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients