Alembic Pharma gets USFDA approval for Doxycycline Capsules USP
DSIJ Intelligence / 31 Jul 2017
Alembic Pharmaceuticals Ltd. has received approval from the USFDA for its abbreviated New Drug Application (ANDA) for Doxycycline Capsules USP, 75 mg and 100 mg, the company said in a BSE filing on Monday.
Alembic Pharmaceuticals Ltd. has received approval from the USFDA for its abbreviated New Drug Application (ANDA) for Doxycycline Capsules USP, 75 mg and 100 mg, the company said in a BSE filing on Monday.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Monodox Capsules, 75 mg and 100 mg, of Aqua Pharmaceuticals, it said, adding that the capsules are indicated for the treatment and prevention of infections that are proven or strongly suspected to be caused by bacteria.
Doxycycline Capsules USP 75 mg and 100 mg have an estimated size of USD 30 million for 12 ending December 2016, according to IMS.
Alembic now has a total of 62 ANDA approvals (54 final approvals and eight tentative approvals) from USFDA.
Alembic Pharmaceuticals was trading at Rs 531.45, down by Rs 12.65 or 2.32% as at 1045 hours on Monday, on the BSE.
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