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Alembic Pharma gets fourth approval from the US drug regulator in a month

Alembic Pharma gets fourth approval from the US drug regulator in a month

Alembic Pharma gets fourth approval from the US drug regulator in a month
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By CNBCTV18.com Nov 14, 2022 4:47:30 PM IST (Published)

Alembic Pharma has a cumulative total of 176 ANDA approvals including 152 final approvals from USFDA.

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Alembic Pharma received its fourth drug approval from the USFDA over the last month on Monday.
The drugmaker received final approval from the regulator for its Cyclophosphamide Capsules, 25 mg and 50 mg.
The product is the theraputic equivalent to Cyclophosphamide Capsules, 25 mg and 50 mg, of Hikma Pharmaceuticals USA Inc. and is used in the treatment of malignant diseases and minimal change nephrotic syndrome in children.

Cyclophosphamide Capsules, which belong to the class of medicines called alkylating agents, are used for treatment of cancer patients. The drug is used in chemotherapy and to suppress the immune system.

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of $8 million for 12 months ended September 2022 according to IQVIA data.

Earlier this month, Alembic Pharmaceuticals had received approval from the USFDA for Ketorolac Tromethamine Injection USP,  Glycopyrrolate Injection USP and for Mesalamine Extended capsule.

Alembic Pharma has a cumulative total of 176 ANDA approvals including 152 final approvals from USFDA.

Shares of Alembic Pharma ended little changed at Rs 640 on Monday.

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