Alembic Pharmaceuticals Receives First USFDA Approval for Peptide Product

On June 17, 2024, Alembic Pharmaceuticals announced that it had received final approval from the US Food & Drug Administration (USFDA) for its Icatibant Injection. This injection, provided in a single-dose prefilled syringe with 30 mg/3 mL concentration (10 mg/mL), is now approved as a generic version of Firazyr Injection by Takeda Pharmaceuticals U.S.A., Inc.

Icatibant injection is used to treat acute attacks of hereditary angioedema (HAE) in adults aged 18 and older. This marks Alembic Pharmaceuticals’ first approval from the USFDA for a peptide product. As reported by IQVIA, the market size for Icatibant Injection is estimated at US$112 million for the twelve months ending March 2024. Overall, Alembic has received 205 approvals from the USFDA for Abbreviated New Drug Applications (ANDA), including 177 final and 28 tentative approvals.

Recent Approvals

In May, Alembic Pharmaceuticals Limited received approvals from the US Food & Drug Administration (USFDA) for five products. These include Diazepam Injection USP 10 mg/2 mL (5 mg/mL), Selexipag Tablets 1,000 mcg and 1,200 mcg, Binimetinib, Tretinoin Cream USP 0.1%, and Clindamycin Phosphate Topical Gel USP 1%.

Financial Highlights

Alembic Pharmaceuticals recorded a 48.02% year-on-year rise in profit after tax (PAT) for the third quarter of FY 2023-24, ending December 31, amounting to ₹180.45 crore. The company also achieved an 8.06% increase in consolidated revenue from operations, reaching ₹1,630.57 crore, compared to ₹1,509.02 crore in the same period last year. The EBITDA saw a year-on-year increase of 14%, reaching ₹269 crore, and sequentially, it rose by 24%.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited is a well-established pharmaceutical company that has been involved in research, development, and manufacturing since 1907. It is publicly traded in India and specialises in producing generic medicines sold worldwide. Alembic operates modern research and manufacturing facilities that meet regulatory standards in several developed countries, including approval from the US FDA. Known for its leadership in branded generics within India, Alembic markets its products through a large team of over 5,000 employees, earning recognition from doctors and patients.

On June 18, 2024, the share price of Alembic Pharmaceuticals Limited opened at ₹909.90, touching the day’s high of ₹915.00 as of 10:27 AM on the NSE.

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