NPIL Pharmaceuticals
Formulations
NPIL Pharmaceuticals
Formulations Overview
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Faclities
 
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
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