Caplin Point Laboratories Limited announced that its subsidiary, Caplin Steriles Limited, received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA). The unannounced inspection, conducted from August 5 to August 9, 2024, at the company’s injectable and ophthalmic manufacturing facility in Gummidipoondi, Tamil Nadu, concluded with zero 483 observations. This highlights Caplin’s adherence to stringent manufacturing and regulatory standards.
Key Highlights:
- Inspection Details: The inspection evaluated compliance with Good Manufacturing Practices (GMP) and regulatory norms, further establishing Caplin Steriles as a reliable pharmaceutical manufacturer.
- Facility Credentials: The facility holds multiple approvals from global regulatory agencies, including USFDA, EU-GMP, ANVISA, and INVIMA.
- Product Portfolio: Caplin Steriles has filed 45 Abbreviated New Drug Applications (ANDAs) in the US, with 31 approvals so far. The company plans to file over 40 injectable and ophthalmic products over the next four years.
About Caplin Steriles Limited:
Caplin Steriles specializes in the development and manufacturing of sterile injectables and ophthalmics for global markets, including the US, Canada, Mexico, and South Africa. It has demonstrated consistent growth in profitability, revenues, and market penetration.
Company Background:
Caplin Point Laboratories focuses on catering to emerging markets in Latin America and Africa with a robust portfolio of dosage forms. The company has been consistently recognized for its financial growth and operational excellence, appearing on Forbes “Asia’s 200 Best Under a Billion” list multiple times.
