Only holder of explosives license for manufacturing of Neat Nitroglycerin for Pharmaceutical use in India.

Unparallel drug substance purity i.e. Lowest Impurity Profile ~ 1/10th of specified limits of official monograph of Pharmacopoeias.
Infrastructure / Plant design compliant with directives of PESO (Petroleum and Explosives Safety Organisation according to Indian Explosives Act.

High manufacturing Capacity of neat Nitroglycerin ~125 kg / day.

USFDA approved manufacturing facility.

Dedicated manufacturing facility, no chance of cross contamination.

Semi-automatic imported Nitroglycerin manufacturing Plant.

Drug Master File

1. Three Drug Master Files (DMFs) submitted to USFDA for following drug substance:

  • Nitroglycerin as in Diluted Nitroglycerin USP DMF No. 22435
  • 17.7% Nitroglycerin in solvated adhesive DMF # 22434
  • Diluted Nitroglycerin USP DMF # 027609

2. Diluted Nitroglycerin USP DMF # 027609 also submitted to regulatory agencies of Malaysia and Singapore.

Certifications

USFDA

State GMP

ISO 9001-2015

1. Three Drug Master Files (DMFs) submitted to USFDA for following drug substance:

  • Nitroglycerin as in Diluted Nitroglycerin USP DMF No. 22435
  • 17.7% Nitroglycerin in solvated adhesive DMF # 22434
  • Diluted Nitroglycerin USP DMF # 027609

2. Diluted Nitroglycerin USP DMF # 027609 also submitted to regulatory agencies of Malaysia and Singapore.

Certifications

USFDA

State GMP

ISO 9001-2015