API Certification

NPIL API facility has following certifications –

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

NPIL also has following product certifications –

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

Itraconazole

• USFDA approval                               : DMF Filed: No.: 16905

In addition to the above, NPIL has approved DMFs for custom manufacturing contracts