International

API Active Pharmaceutical Ingredients

Bal Pharma API (Active Pharmaceutical Ingredients) business began in 1996 with a simple objective of facilitating the manufacture of niche molecules that have been able to take the benefits of vertical integration to international and domestic markets.

Bal Pharma’s API business has the competence and knowledge to undertake more than 30 different types of complex chemical reactions. Whether these are Advance Intermediates, Fine Chemicals or Active Pharmaceuticals Ingredients, the company can seamlessly scale up from MG to MT quantities. It offers various activities like:

  State-of-the-art Pilot and Commercial Scale multipurpose facilities

  Pharmaceutical Manufacturing Plants conforming to GMP guidelines

  R & D facilities to support early development of Generic APIs

  Patent non-infringing processes

  High quality documents – Drug master file

The API products are being exported to Japan, Australia, Spain, UK, Canada, Nigeria, Iceland, Slovenia, Romania, Argentina, Brazil, Pakistan, Germany, South Africa, Serbia, Taiwan, Malaysia, Thailand, Turkey, Egypt, Korea, Venezuela, Italy, Portugal, Morocco, Poland, Netherlands, Syria, Bangladesh and Indonesia etc.

The range of APIs includes Anti-Histamine, Platelet Inhibitor, Anti-Diabetic, Anti Convulsant, Urinary Incontinence, Neuropathic Pain, Anti Allergy, Anti Inflammatory, Diuretic, Acne Treatment etc.

The plant has various accreditations.

Certification

  ISO 9001 – 2008

  Approval from EDQM for Gliclazide and Ebastine

  TGA approval for Gliclazide

  Approval from KFDA for Gliclazide and Ebastine

  COFEPRIS, MEXICO approval for Benzydamine HCl, Ebastine and Tolterodine tartrate

  Plant approved by MOH Iran and MOH Canada

  Only Indian company to be granted a COS for Gliclazide

  One of the first Indian companies to successfully file and receive approval by MHLW Japan