Overview

Bharat Pharma (A unit of Bharat Explosives Limited) is a dedicated facility for manufacturing of variants of Nitroglycerin drug substance by diluting neat nitroglycerin in various inert mediums. The facility is US FDA approved conforming to provisions of State GMP, ISO 9001-2015 and compliant with The Explosives Act, 1884 for manufacturing of neat nitroglycerin.

Bharat Pharma is the only company in India, holding the License granted by Petroleum and Explosives Safety Organization (PESO), Ministry of Industry, Govt of India, to manufacture neat Nitroglycerin for Pharmaceutical use, under the provisions of The Explosives Act, 1884.

Mission

Strive to achieve high ethical standards by utilizing best available equipment and personnel to promote, develop and manufacture Energetic materials and drug substances with the set motto of Best Quality, On Time, Every Time.

Differentiators

  • Only holder of explosives license for manufacturing of Neat Nitroglycerin for Pharmaceutical use in India.
  • Infrastructure / Plant design compliant with directives of PESO (Petroleum and Explosives Safety Organisation according to The Explosives Act, 1884.
  • USFDA approved manufacturing facility.
  • Dedicated manufacturing facility, no chance of cross contamination.
  • Semi-automatic imported Nitroglycerin manufacturing Plant.

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

  • Nitroglycerin as in Diluted Nitroglycerin USP
  • 17.7% Nitroglycerin in solvated adhesive
  • Diluted Nitroglycerin USP

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

Certifications

USFDA

State GMP

ISO 9001-2015