Pantoprazole Injection Manufacturer in India

Product Details

Pantoprazole Injection — manufactured at 9M India

Product Specifications

Generic Name: Pantoprazole Sodium Sesquihydrate
Strength: 40mg (as Pantoprazole)
Dosage Form: Powder for Solution for Injection or Infusion
Route: Intravenous (IV)
Container: Type I glass vial — 10mL
Closure: Rubber stopper + aluminium flip-off crimp seal
Storage: Store below 25°C · Protect from light · After reconstitution: use immediately
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

Pantoprazole IV is the most widely prescribed intravenous proton pump inhibitor — used for acute management of peptic ulcer disease, GI bleeding prophylaxis, GERD in patients unable to take oral medications, and stress ulcer prophylaxis in critically ill patients. On the WHO Essential Medicines List. Among the highest-volume dry powder injectables tendered by government hospitals and institutional buyers in India and export markets.

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Manufacturing & Compliance

How Pantoprazole Injection is manufactured at 9M India

Sterile cleanroom manufacture

Pantoprazole Sodium solution is prepared under controlled pH (>10.5 to maintain stability), sterile-filtered and aseptically filled into Type I glass vials. Lyophilised (freeze-dried) under validated freeze-drying cycles to produce a white/off-white cake. The lyophilised product is sealed under nitrogen atmosphere to prevent oxidation. Reconstitution studies validated at 0.9% Sodium Chloride and 5% Dextrose.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (<0.25 EU/mg) · Appearance of cake · Reconstitution time and clarity · pH of reconstituted solution (9.0–11.0) · Assay by HPLC (95.0–105.0%) · Related substances · Water content by Karl Fischer (<3.0%) — 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.