Alembic Pharma Share Price Dips After USFDA Flags Four Observations for Panelav Facility

Market Performance

Alembic Pharma's share price dropped nearly 2% in early trading on June 2 due to the US Food and Drug Administration's regulatory evaluation.

• Opening Quote (09:29 AM): ₹1,000.05
• Fall: ₹17.15 or 1.69%
• Exchange: BSE

The drop comes after the company disclosed receipt of four observations from the United States Food and Drug Administration (USFDA) for its API-I & II facility at Panelav, Gujarat.

• 52-week high: ₹1,296.15 (as of October 9, 2024)
• 52-week low: ₹725.60 (as of March 3, 2025)
• Current price: 22.84% below 52-week high and 37.82% above 52-week low
• Market Capitalisation: ₹19,657.30 Crore

USFDA Observations Trigger Stock Reaction

From May 26 to May 31, 2025, the US Food and Drug Administration conducted a routine inspection that included an unannounced visit at the Panelav facility.The inspection was focused on current Good Manufacturing Practices (cGMP).

Following the inspection:

• A Form 483 was issued with four observations.
• No data integrity concerns were flagged.
• Alembic Pharma stated that the observations are addressable.
• The company intends to provide a detailed response to the USFDA within the prescribed timeline.

Company Updates: Recent USFDA Approvals

Despite the regulatory development, Alembic Pharma continues to make headway in product approvals:

• May 30, 2025: Received final USFDA approval for Bosutinib Tablets (100 mg & 500 mg), used to treat Philadelphia chromosome-positive chronic myelogenous leukemia (CML)
• May 23, 2025: Secured USFDA approval for Amlodipine and Atorvastatin Tablets USP across a wide dosage range from 2.5 mg/10 mg to 10 mg/80 mg

These approvals reflect the company's ongoing efforts to expand its portfolio of generic drugs in the US market.

Company Details

 The Panelav facility is one of its key API manufacturing units.

The company's robust pipeline and global compliance focus continue to anchor its position in regulated markets.

Summary

The Alembic Pharma share price took a hit after the USFDA issued four observations for its Panelav facility, leading to a nearly 2% decline in early trade. However, the company confirmed that there were no data integrity issues and that it would respond to the regulator within the allowed timeframe.

Meanwhile, Alembic's momentum in securing US FDA approvals for critical generics, such as Bosutinib and Amlodipine-Atorvastatin combination tablets, demonstrates its commitment to growth in the US market, even amid regulatory hurdles.