Granules India inaugurated and launched its packaging facility through its Granules Consumer Health (GCH) step-down subsidiary which is located in Manassas, Virginia, US.

The facility is over 79,000 square feet and is equipped with packaging lines and clean rooms to package and ship prescription and over-the-counter products across the US market. The facility recently received US FDA approval with zero 483 observations.

The state-of-the-art facility was inaugurated by Ambassador Taranjit Singh Sandhu who serves as India’s Ambassador to the United States. In addition, Ambassador (ret) Atul Keshap, President of the US India Business Council, Jasjit Singh, Executive Director of Select USA, Scott Melville, President of the Consumer Healthcare Products Association and Chris Shorter County Executive of Prince William County were on hand for the inauguration.
 
“Granules Consumer Health’s packaging facility will improve resilience in our supply chain as well as improve our reaction time. The facility will enable us to meet fast-moving consumer shifts as well as reduce lead times for critical prescription products that are in shortage” said Dr Krishna Prasad Chigurupati, CMD, Granules India.
 
The addition of a US packaging facility will result in Granules being among the few pharmaceutical companies to be vertically integrated from API to packaging, Granules has invested approximately $12.5 million into its US packaging facility.

Granules India also received ANDA Approval for Gabapentin tablets. The company announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP, 600 mg and 800 mg. It is bioequivalent to the reference listed drug product (RLD), Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty.
 
Gabapentin Tablets are indicated for the management of postherpetic neuralgia in adults; and as an adjunctive therapy in the treatment of partial-onset seizures, with and without secondary generalization, in adults and pediatric patients three years and older with epilepsy.
 
Granules now have a total of 55 ANDA approvals from the US FDA (53 Final approvals and 2 tentative approvals).