Gland Pharma gets USFDA EIR for Pashamylaram Facility
Hyderabad: Gland Pharma has announced that the Company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) indicating the inspection closure at its Pashamylaram Facility in Hyderabad.
The US regulator had conducted the Pre-Approval Inspection (PAI) for Seven (7) products and Good Manufacturing Practice (GMP) Inspection at the facility between 15th June, 2023 and 27th June, 2023 and issued one 483 observation.
Read also: Gland Pharma gets one USFDA observation for Pashamylaram Facility
Gland Pharma, a generic injectable-focused pharmaceutical company, was established in 1978 in Hyderabad. The Company is present in sterile injectables, oncology and ophthalmic segments, and focuses on complex injectables including NCE-1s, First-to-File products and 505(b)(2) filings. Its products are currently delivered via liquid vials, lyophilized vials, pre-filled syringes, ampoules, bags and drops; and its efforts are underway to augment additional manufacturing capabilities in complex injectables such as peptides, long-acting injectables, suspensions and hormonal products.
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