The U.S. Food and Drug Administration (U.S. FDA) has approved Granules India’s abbreviated new drug application for Gabapentin Tablets USP, 600 mg and 800 mg.
The approved product is bioequivalent to Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC, the drugmaker said on Wednesday.
The current annual U.S. market for Gabapentin tablets, which are indicated for management of postherpetic neuralgia in adults and as an adjunctive therapy in treatment of partial onset seizures, is about $145 million, Granules said citing MAT Jan 2023 IQVIA/IMS Health numbers. The company said it now has 55 ANDA approvals from the U.S. FDA (53 final approvals and two tentative approvals).
Packaging unit opened
In another development, a 79,000 sq. ft packaging facility of the drugmaker’s step-down subsidiary Granules Consumer Health (GCH) in Manassas, Virginia, U.S., has been inaugurated.
The facility, in which Granules has invested about $12.5 million, is equipped with packaging lines and clean rooms to package and ship prescription and over-the-counter products across the U.S. market and received U.S. FDA approval with zero 483 observations. The addition of a U.S. packaging facility makes Granules one of the few pharmaceutical companies to be vertically integrated from API to packaging, the company said.
“GCH packaging facility will improve resilience in our supply chain… enable us to meet fast-moving consumer shifts as well as reducing lead times for critical prescriptions products that are in shortage,” Granules India CMD Krishna Prasad Chigurupati said. India’s Ambassador to the U.S. Taranjit Singh Sandhu inaugurated the facility. On Wednesday, Granules shares closed with a less than 1% gain at ₹273.20 apiece on the BSE.
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