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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