Alembic Pharma receives USFDA approval for anti-bacterial drug

Alembic Pharmaceuticals Limited on Monday announced that it has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Doxycycline capsules USP (75 mg and 100 mg), which is used in the treatment and prevention of infections that are strongly suspected to be caused by bacteria.


The approved ANDA is therapeutically equivalent to the reflence listed drug product (RLD) Monodox capsules 75 mg and 100 mg of Aqua Pharmaceuticals.

Doxycycline capsules have an estimated market size of $30 million, according to MIS.

With this recent approval, the Vadodra-headquartered company now has a total of 62 ANDA approvals from the US drug regulator.


Earlier this month, Alembic started a Rs 300 crore anti-cancer drug facility at Halol in Gujarat. The unit, which will soon start exporting oncology products to US, Middle East, North Africa, Australia and South Africa, has the capacity to manufacture 60 million tablets/capsules and approximately 20 million vials of liquid injectable and lyophilized concentrates.

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