Natco Pharma
Overview
Natco Pharma is a leading pharmaceutical company based in India, specializing in the development and manufacturing of pharmaceutical products. The company is renowned for its focus on research and development in the area of generic and specialty medicines.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Natco Pharma is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
FDA compliance signals
16 FDA enforcement records linked to this company.
- 4832025-06-19
Validation lacking for sterile drug products
- 4832025-06-19
Buildings of Suitable Size, Construction, Location
- 4832025-06-19
Procedures for sterile drug products
- 4832025-06-19
Investigations of discrepancies, failures
- 4832025-06-19
Cleaning / Sanitizing / Maintenance
- 4832025-06-19
Procedures not in writing, fully followed
- 4832025-06-19
Environmental Monitoring System
- recall — Class II2024-04-17
CGMP Deviations
- warning_letter2024-04-08
FDA Warning Letter (drug product)
- recall — Class II2024-02-14
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
- 4832017-01-24
Mix-up
- 4832017-01-24
Procedures for sterile drug products
- 4832017-01-24
Released Drug Products Area
- 4832017-01-24
Scientifically sound laboratory controls
- 4832017-01-24
Procedures not in writing, fully followed
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