Alembic Pharmaceuticals announces USFDA Final Approval for Doxycycline Capsules, 40 mg

On June 28th, 2024, Alembic Pharmaceuticals Limited disclosed receiving final approval from the US Food & Drug Administration (USFDA) for its Doxycycline Capsules, 40 mg.

Doxycycline Capsules treat inflammatory skin lesions (papules and pustules) caused by rosacea in adults. The approval means Alembic’s version is equivalent in effectiveness to the reference drug, Oracea Capsules, 40 mg, from Galderma Laboratories, L.P.

According to IQVIA, the market size for Doxycycline Capsules, 40 mg, is estimated to be around US$ 123 million for the 12 months ending March 2024. Alembic has now accumulated 205 approvals from the USFDA for its Abbreviated New Drug Applications (ANDAs), including 179 final and 26 tentative approvals.

Recent Approval

On June 18, 2024, Alembic Pharmaceuticals Limited announced final approval for their Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules in 75 mg and 150 mg strengths, with tentative approval for the 110 mg strength. These capsules are medically equivalent to Pradaxa Capsules from Boehringer Ingelheim Pharmaceuticals, Inc.

On June 17, 2024, Alembic Pharmaceuticals Limited disclosed that it has secured final approval from the USFDA for its ANDA for Icatibant Injection in a 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe. This approval confirms that Alembic’s product is equivalent in therapeutic effect to Firazyr Injection, 30 mg/3 mL (10 mg/mL), from Takeda Pharmaceuticals U.S.A., Inc. Icatibant injection is specifically used to treat acute episodes of hereditary angioedema (HAE) in adults aged 18 and above.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited is a pharmaceutical company with a long history dating back to 1907. Based in India, it operates globally as a manufacturer and marketer of generic drugs. Alembic is known for its advanced research and manufacturing facilities, which meet the stringent regulatory standards of several developed countries, including the USFDA. In India, Alembic is a leading provider of branded generic medicines, widely respected by healthcare professionals and patients. The company’s extensive portfolio is supported by a large marketing team that promotes its products worldwide.

On June 28, 2024, the share price of Alembic Pharmaceuticals Limited opened at ₹880.00, touching the day’s high at ₹900.20, as of 02:50 PM on the NSE.

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