Alembic Pharma has received the first approval from the United States Food and Drug Administration (USFDA) for its Jarod Facility’s formulation division IV located in Vadodara district of Gujarat.
The company informed bourses on Thursday that the USFDA has given it a Prior Approval Supplement (PAS) authorisation for its Supplemental Abbreviated New Drug Application (sANDA) for Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.
Pregabalin capsule is used for treatment of epilepsy, anxiety and nerve pain.
The approval is the first from the Jarod Facility, with the company already receiving the ANDA for its Panelav facility in Panchmahal district of Gujarat. With the new approval, Alembic Pharma now holds 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.
The company recently received the Establishment Inspection Report (EIR) for its oncology injectable formulation facility in Panelav. It also recently received the USFDA approval for a skin infection cream, Desonide, and Diclofenac Sodium Topical Solution, which is used to treat pain caused by osteoarthritis.
Pregabalin is the therapeutic equivalent of reference listed drug product (RLD) Lyrica Capsules, which are produced by Upjohn. Pregabalin capsule has an estimated market size of $244 million in the US for the one-year period ending September 2022, according to the IQVIA data.
Shares of Alembic Pharma are trading 1.4 percent lower at Rs 589.35.
