Eugia Pharma Specialities Limited
Overview
Pharmaceutical manufacturing site surfaced via EU GMP non-compliance screening (EudraGMDP).
Core services & business areas
API / Drug Master Files
Eugia Pharma Specialities Limited holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- MEROPENEM FOR INJECTION (STERILE BULK)Active2013-06-18
FDA compliance signals
34 FDA enforcement records linked to this company.
- eu_noncompliance2026-03-27
EU GMP Statement of Non-Compliance
- 4832026-02-06
Sterility/pyrogens - test methods written, followed
- 4832026-02-06
Procedures for sterile drug products
- 4832026-02-06
Equipment to control conditions
- 4832026-02-06
Investigations of discrepancies, failures
- 4832026-02-06
Training--operations, GMPs, written procedures
- 4832026-02-06
Procedures not in writing, fully followed
- 4832026-02-06
Environmental Monitoring System
- 4832026-02-06
Validation lacking for sterile drug products
- 4832026-02-06
Following/documenting laboratory controls
- 4832026-02-06
Testing and release for distribution
- 4832026-02-06
Second person sign off
- warning_letter2024-08-15
FDA Warning Letter (drug product)
- 4832024-05-03
Mfg / Processing Operations Area
- 4832024-05-03
Validation lacking for sterile drug products
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