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The sANDA, submitted as PAS provides for an alternate drug product manufacturing site to company's formulation division IV, Jarod, Gujarat, India as previously approved ANDA from Panelav facility (F-I). This is the first product approval from Jarod Facility which was inspected in December 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 $244 million for twelve months ending Sep 2022 according to IQVIA.
Alembic has received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
On consolidated basis, the company's net profit declined 18.7% to Rs 133.35 crore despite of 14.1% jump in revenue from operations to Rs 1,475.01 crore in Q2 FY23 over Q2 FY22.
Shares of Alembic Pharmaceuticals were down 1.05% to Rs 591.10 on the BSE.
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