The U.S. Food and Drug Administration (U.S. FDA) has authorized Granules India’s abbreviated new drug utility for Gabapentin Tablets USP, 600 mg and 800 mg.
The authorized product is bioequivalent to Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC, the drugmaker mentioned on Wednesday.
The present annual U.S. market for Gabapentin tablets, that are indicated for administration of postherpetic neuralgia in adults and as an adjunctive remedy in remedy of partial onset seizures, is about $145 million, Granules mentioned citing MAT Jan 2023 IQVIA/IMS Health numbers. The firm mentioned it now has 55 ANDA approvals from the U.S. FDA (53 ultimate approvals and two tentative approvals).
Packaging unit opened
In one other improvement, 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, through which Granules has invested about $12.5 million, is provided with packaging strains and clear rooms to bundle and ship prescription and over-the-counter merchandise throughout the U.S. market and obtained U.S. FDA approval with zero 483 observations. The addition of a U.S. packaging facility makes Granules one of the few pharmaceutical firms to be vertically built-in from API to packaging, the corporate mentioned.
“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 mentioned. India’s Ambassador to the U.S. Taranjit Singh Sandhu inaugurated the power. On Wednesday, Granules shares closed with a lower than 1% achieve at ₹273.20 apiece on the BSE.
