Drug Approval | September 02, 2022
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.
There are no data integrity (DI) observations.
With the receipt of the EIR, the inspection stands successfully closed.
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
With this expansion, the Grand Island site provides redundant capacity to support global supply of media and further extends the site’s capabilities to produce the high-quality technology and materials needed for the development and commercial manufacturing of vaccines and biologic therapies
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