The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
This product will be manufactured at Lupin’s Nagpur facility in India
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension
Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad
Indoco is comprehensively working on the remedial action plan
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
The company can now expand its business horizon into the area of pharmaceutical applications in the USA
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