Alembic Pharmaceuticals on Monday said that its Derma facility located at Karakhadi in Vadodara, Gujarat, has successfully undergone inspection by the United States Food and Drug Administration (USFDA) with no observation.
The inspection was conducted by the US drug regulator between March 6 to March 10, 2023, the company said in a filing to the stock exchanges.
The company, on February 16 had received an Establishment Inspection Report (EIR) from the USFDA for its F-3 unit at Karkhadi following an inspection between August 18-30, 2022.
Last week, the company received tentative approval from the USFDA for Brexpiprazole tablets, which are used in the treatment of major depressive disorder and for treatment of schizophrenia.
Prior to that, the company received final approval from USFDA for Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) pharmacy bulk vial. The injection is used for treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma.
The company manufactures and markets generic pharmaceutical products across the globe.
Earlier, the Vadodara-based drugmaker announced that it will be taking an impairment charge of Rs 1,150.43 crore pertaining to its three under-construction manufacturing plants in Gujarat.
The company mentioned that the USFDA approval processes for these manufacturing facilities took longer than anticipated due to Covid-19.
Shares of Alembic Pharma are trading 1.6 percent lower at Rs 490.80.
