Glenmark Pharmaceuticals Receives US
Glenmark Pharmaceuticals Receives US FDA Compliance Report for Monroe Manufacturing Facility
Glenmark Pharmaceuticals has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its formulations manufacturing facility located in Monroe, North Carolina. The EIR signifies the completion of an inspection conducted by the regulatory agency, indicating compliance with applicable requirements.
The Monroe facility underwent a thorough review by the US FDA, which evaluates adherence to Good Manufacturing Practices (GMP) and other regulatory standards. The issuance of the EIR confirms that Glenmark’s operations at this site meet these standards. This development follows routine inspections conducted by the agency to ensure pharmaceutical manufacturing facilities maintain quality and safety protocols.
Monroe, US
Spread across 105,000 sq. ft., this facility is dedicated to the manufacturing of sterile injectable products (vial and pre-filled syringes). Estimated investment is approximately USD 100 M over five years. Regulatory Approvals - US-FDA.
Annual Capacity
Oral solids: 300 – 400 Mn tablets and capsules
Injectable: 20 – 25 M vials and pre-filled syringes
Inhalation: 25 – 30 mn ampules
Markets – USA
Glenmark Pharmaceuticals Limited is an Indian multinational pharmaceutical company headquartered in Mumbai. Glenmark Pharmaceuticals was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer. He named the company after his two sons. The company initially sold its products in India, Russia, and Africa. The company went public in India in 1999. Saldanha's son Glenn took over as CEO in 2001, having returned to India after working at PricewaterhouseCoopers. Glenmark won the esteemed 'Excellence in Sustainability' award at the India Pharma Awards 2023.
