Alembic Pharma gets PAS approval from USFDA for Pregabalin Capsules
Pregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications.
Mumbai: Alembic Pharmaceuticals Limited today announced that the company has received PAS (Prior Approval Supplement) approval from the US Food & Drug Administration (USFDA) for its Supplemental Abbreviated New Drug Application (sANDA) Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.
The sANDA, submitted as "Prior Approval Supplement," provides for an alternate drug product manufacturing site - Alembic Pharmaceuticals Limited, Formulation Division IV, Jarod, Gujarat, India for previously approved ANDA from Panelav Facility (F-I). This is the first product approval from Jarod Facility which was inspected in Dec 2022.
The approved sANDA is therapeutically equivalent to the reference listed drug product (RLD), Lyrica Capsules, of Upjohn. Pregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications.
Pregabalin Capsules have an estimated market size of US$ 244 million for twelve months ending Sep 2022 according to IQVIA.
Alembic has a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.
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Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. It is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. Products under International Generics are manufactured across our world-class facilities in Panelav, Karkhadi, and Jarod in Gujarat. Under this vertical, the company also has R&D facilities in Vadodara (Gujarat), Hyderabad (Telangana), and New Jersey (USA).
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