Alembic Pharmaceuticals Received USFDA Form 483 With 5 Procedural Observations

This marked a significant milestone for Alembic as it became one of the first Indian companies to produce penicillin, a groundbreaking antibiotic that revolutionized the field of medicine. The success in penicillin production paved the way for Alembic to expand its pharmaceutical portfolio and become a leading player in the industry. Over the years, Alembic continued to innovate and diversify its product offerings, venturing into various therapeutic segments such as cardiovascular, anti-infective, and central nervous system drugs. The company’s commitment to research and development led to the introduction of several novel drug formulations and technologies, further solidifying its position as a trusted pharmaceutical brand. Today, Alembic Pharmaceuticals Limited stands as a global pharmaceutical powerhouse with a strong presence in over 75 countries. 

Alembic Pharma Gujarat facility receives five observations from the USFDA

Alembic Pharmaceuticals informed that the US Food and Drug Administration (USFDA) has concluded its Good Manufacturing Practice (GMP) inspection with five procedural observations at its solid oral formulation facility located in Jarod, Gujarat. The GMP inspection was conducted from 14 November 2024 to 22 November 2024. The USFDA issued Form 483 with 5 observations.

The company stated that it would provide a comprehensive response to the USFDA for the observations within the stipulated period. It is also committed to maintaining the highest quality standards and compliance at all times.

Alembic Pharmaceuticals Q2 FY25 result

The pharmaceutical company’s consolidated net profit increased 12.3% to Rs 153.41 crore in Q2 FY25 as compared to Rs 136.56 crore posted in Q2 FY24. Revenue from operations grew 3.3% year on year (YoY) to Rs 1,647.98 crore in the quarter ended 30 September 2024.

Alembic Pharmaceuticals stock price is up by 4%

Alembic Pharmaceuticals’ stock price is right now trading at Rs. 1,080.00 per share and the high traded price is Rs. 1,097.20 where stock is far away from 52-week’s high price of 1303.90 per share.

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