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Niche Generics & Intermediates – Certifications

Certifications

API facility has following certifications

  • USFDA (without any 483)
  • TGA
  • WHO
  • ISO 9001, ISO 14000
  • MCA
  • European and Canadian Drug Authorities approvals

Product certifications are :

Diltiazem Hydrochloride
USFDA approval : DMF No: 14713
European Certificate of Suitability : R1-CEP 1997-121-REV 01
TGA Australia : GMP certificate No. 1318
Ketoconazole
USFDA approval : DMF Filed: No: 17290
European Certificate of Suitability : R0-CEP 1999-049-REV 02
Canadian Drug Authority : DMF filed
Verapamil
USFDA approval : DMF Filed: No.: 16605
Verapamil
USFDA approval : DMF Filed: No.: 16905
In addition to the above, NPIL has approved DMFs for custom manufacturing contracts