USFDA issues 2 observations for Alembic Pharma Karkhadi facility

Alembic Pharmaceuticals’ API facility located at Karkhadi was inspected by US Food and Drug Administration (USFDA) from January 13-17, 2020.

This was a scheduled pre-approval inspection and at the end of the inspection, USFDA issued form 483 with two observations.

Last week, the company received an USFDA tentative approval for Empagliflozin tablets, 10 mg and 25 mg. Emapgliflozin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Also, it got a final approval from USFDA for Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg.

The company’s management expects the number of ANDA filings would be around 25 in FY20. It has already launched three products in US and has guided for 10-15 launches for FY20.

Alembic Pharma is engaged in developing formulations and Active Pharmaceutical Ingredients (APIs). The company focusses on anti-infective, analgesic, cough and cold therapies. It also focusses on therapies such as cardiology, diabetes, gynaecology, gastrointestinal, orthopaedic, dermatology and ophthalmology.

On Monday, the stock of Alembic Pharma had closed at Rs 598.75. On Tuesday, in the early morning session, it was trading at Rs 590.10, down by 1.4 per cent.