Heparin Sodium

Heparin Sodium A.P.I. (IP/BP/USP)


Heparin Sodium an anticoagulant used in surgery, kidney dialysis and other clinical applications, is produced from a single source of raw material: bovine intestine – a by-product of the beef industry. Heparin products have long been used in the treatment of thrombotic conditions. The worldwide heparin market is approximately $7 billion per year, with more than half of this market consisting of low molecular weight (LMW) heparin.

Even with the advent of new anticoagulants, it is anticipated that for the foreseeable future heparin and LMW heparin will remain standard clinical therapy and a necessary component of successful surgeries and interventional procedures.
Heparin can be obtained in commercial quantities from intestinal mucosa (cow, pig, sheep) and lung (cow). Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties. It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated or N-acetylated) and O-sulphated uronic acid (α-L-iduronic acid or β-D-glucuronic acid).

Heparin Sodium API Manufacturing is a sterile preparation of heparin sodium derived from bovine intestinal tissue, standardized for anticoagulant activity, in water for injection. It is intended for intravenous or deep subcutaneous administration. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.

Bacto Chem Plant Capacity:
>150 Tones per annum

Grade:
Injectable/Topical/Crude

Specification:
IH

Heparin Sodium Injection is indicated for:

  • Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
  • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;
  • Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
  • Prevention of clotting in arterial and cardiac surgery;
  • Prophylaxis and treatment of peripheral arterial embolism;
  • Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.

Structure of heparin sodium

Heparin Sodium from Bacto Chem

Bacto Chem is one of the only companies to manufacture bovine sourced Heparin Sodium from biomass in India. Our product follows the Indian Pharmacopeial standards, and our product has a potency of 160 IU/mg to match the global potency values of bovine Heparin Sodium.

All Bacto Chem Products are manufactured in compliance with the World Health Organization (WHO) Current Good Manufacturing Practices (cGMP) under strict conditions in state-of-the-art facilities. This results in products that are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. Each of our products is manufactured in a dedicated block with no cross-contamination.

Our strengths lie in our highly trained and experienced QC department which ensures all the raw materials go through stringent testing prior to their utilisation, ensuring that only raw materials of the highest quality are used only after approval from QC. We ensure that all our equipment and manufacturing process are thoroughly validated and updated. We invest heavily on training our production and QC teams to understand and monitor every stage of the production cycle to ensure safety and highest quality product. Maintaining cleanliness is our responsibility, and we always focus on ensuring proper measures are taken to follow our validates cleaning protocols to avoid batch to batch contamination.

Additionally, Bacto Chem is compliant with the requirements of OHSAS 18001:2007 in occupational health and safety management systems. Bacto Chem is also ISO 14001:2015 certified which recognizes us as an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability and has the necessary Halal certifications as well.