Heparin Injection Manufacturer in India

Product Details

Heparin Injection — manufactured at 9M India

Product Specifications

Generic Name: Heparin Sodium (from porcine intestinal mucosa)
Strength: 5000 IU/mL · 25000 IU/mL
Dosage Form: Solution for Injection or Infusion
Route: Subcutaneous (SC) · Intravenous (IV)
Container: Type I glass vial — 1mL · 5mL · 10mL
Closure: Rubber stopper + aluminium crimp seal
Storage: Store below 25°C · Protect from light
Shelf Life: 24 months
Manufacturing: WHO-GMP certified sterile cleanroom · Grade A/B aseptic fill-finish
Regulatory Status: DCGI approved · Manufacturing licence held
Available For: Contract manufacturing · Third-party manufacturing · Direct supply

Heparin Sodium injection is one of the oldest and most essential anticoagulants in clinical practice — used for DVT and PE treatment and prevention, anticoagulation during cardiac surgery, hemodialysis, and in acute coronary syndromes. On the WHO Essential Medicines List. One of the highest-volume parenteral anticoagulants procured by government hospitals, surgical centres and ICUs worldwide.

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Manufacturing & Compliance

How Heparin Injection is manufactured at 9M India

Sterile cleanroom manufacture

Heparin Sodium solution is prepared from pharmacopoeial-grade porcine mucosa-derived Heparin in Water for Injection with appropriate preservative system and pH adjustment to 5.0–7.5. Sterile-filtered through 0.22 micron membrane and aseptically filled into Type I glass vials under Grade A laminar airflow. Biological potency (anti-Xa and anti-IIa activity) tested on every batch in addition to standard chemical QC.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (LAL, <0.03 EU/IU Heparin for IV products) · pH (5.0–7.5) · Biological potency by anti-Xa chromogenic assay · Protein content · Nucleotides · Visible particulate matter — all tested in-house. COA per batch with biological potency certificate.
Documentation available within 24 hours

DCGI manufacturing licence · WHO-GMP Certificate · Certificate of Analysis · Certificate of Conformance · Stability data (real-time and accelerated, ICH-aligned) · Batch manufacturing record summary — pre-prepared and available within 24 hours for tender submission, export registration or CDMO due diligence.