Adenosine Injection Manufacturer in India

Product Details

Adenosine Injection — manufactured at 9M India

Product Specifications

Generic Name: Adenosine
Strength: 3mg/mL (6mg/2mL · 12mg/4mL)
Dosage Form: Solution for Injection
Route: Rapid Intravenous Bolus (IV)
Container: Type I glass vial — 2mL (6mg) · 4mL (12mg)
Closure: Rubber stopper + aluminium crimp seal
Storage: Store between 15–30°C · Do not refrigerate · 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

Adenosine IV is the first-line pharmacological treatment for paroxysmal supraventricular tachycardia (PSVT) — a cardiac emergency requiring immediate intervention. It is also used diagnostically in cardiac stress testing when exercise testing is not possible. Rapid bolus IV administration converts PSVT to sinus rhythm within 10–30 seconds in over 90% of cases. Essential emergency medicine item on all hospital formularies.

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Manufacturing & Compliance

How Adenosine Injection is manufactured at 9M India

Sterile cleanroom manufacture

Adenosine aqueous solution prepared in Water for Injection at 3mg/mL concentration without pH adjusters — Adenosine is inherently pH neutral in solution. Sterile-filtered through 0.22 micron membrane and aseptically filled into Type I glass vials under Grade A laminar airflow. Stored at controlled room temperature — refrigeration must be avoided as Adenosine crystallises at low temperatures.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (<0.25 EU/mL) · pH (4.5–7.5) · Assay by HPLC (90.0–115.0%) · Related substances (adenine, hypoxanthine, inosine) · Visible particulate matter · Absence of crystals — all in-house. COA per batch.
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.