Alembic Pharma Secures USFDA Clearance for Panelav Facilities, Reports 15% Profit Growth
Alembic Pharmaceuticals received Establishment Inspection Reports (EIRs) from USFDA for its API-I and API-II facilities in Panelav, Gujarat. The company also got USFDA approval for Macitentan Tablets. Financially, Alembic reported a 15% increase in net profit to ₹154 crore, 10% revenue growth to ₹1,711 crore, and improved EBITDA margin of 16.50% in the latest quarter.

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Alembic , a prominent player in the Indian pharmaceutical sector, has received positive news from the U.S. Food and Drug Administration (USFDA) while also reporting strong financial performance in its latest quarterly results.
USFDA Clearance for Manufacturing Facilities
Alembic has announced the receipt of an Establishment Inspection Report (EIR) from the USFDA for its API-I and API-II facilities located in Panelav, Gujarat. This follows an inspection conducted between May 26-31. The EIR is a significant milestone, indicating that these manufacturing sites are in compliance with regulatory standards.
This recent clearance adds to the company's regulatory successes. In June, Alembic had previously received an EIR for its API-III facility at Karakhadi, following an inspection in March of the same year.
New Drug Approval
In a separate development, Alembic secured final USFDA approval for its Macitentan Tablets, 10 mg, a generic drug application, on August 19. This approval expands the company's portfolio in the U.S. market.
Strong Quarterly Performance
Alembic has reported robust financial results for the latest quarter:
Financial Metric | Current Quarter | Previous Year Quarter | Year-on-Year Change |
---|---|---|---|
Net Profit | ₹154.00 | ₹135.00 | 15.00% |
Revenue | ₹1,711.00 | ₹1,555.00 | 10.00% |
EBITDA | ₹282.00 | ₹237.00 | 19.00% |
EBITDA Margin | 16.50% | 15.20% | 1.30 percentage points |
The company's EBITDA margins showed improvement, increasing from 15.20% to 16.50% year-on-year.
Stock Performance
At the close of trading, Alembic's shares were priced at ₹945.40 on the National Stock Exchange (NSE), representing a marginal decline of 0.18%.
These developments, including regulatory clearances and strong financial performance, underscore Alembic's efforts to strengthen its position in both domestic and international markets.
Historical Stock Returns for Alembic
1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
---|---|---|---|---|---|
+2.25% | +1.99% | -0.92% | +17.07% | -28.08% | -6.36% |