Methylprednisolone Injection Manufacturer in India

Product Details

Methylprednisolone Injection — manufactured at 9M India

Product Specifications

Generic Name: Methylprednisolone Sodium Succinate
Strength: 40mg · 125mg · 500mg (as Methylprednisolone)
Dosage Form: Powder for Solution for Injection or Infusion
Route: Intravenous (IV) · Intramuscular (IM)
Container: Type I glass vial — 40mg/2mL · 125mg/2mL · 500mg/8mL after reconstitution
Closure: Rubber stopper + aluminium flip-off crimp seal
Storage: Store below 25°C · Protect from light · Reconstituted solution: use within 48 hours at 2–8°C
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

Methylprednisolone IV is a high-potency corticosteroid used across multiple critical conditions — acute spinal cord injury (high-dose protocol), severe asthma and COPD exacerbation, autoimmune conditions (MS relapse, lupus flare, vasculitis), organ transplant rejection, and severe allergic reactions. The 500mg strength is particularly used in pulse therapy for serious inflammatory conditions. High-demand item in ICUs, neurology units, transplant centres and emergency departments.

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Manufacturing & Compliance

How Methylprednisolone Injection is manufactured at 9M India

Sterile cleanroom manufacture

Methylprednisolone Sodium Succinate is dissolved in Water for Injection, pH adjusted to 7.0–8.0, sterile-filtered and aseptically filled into Type I glass vials. Lyophilised (freeze-dried) under validated freeze-drying cycles to produce a white crystalline cake. Sealed under nitrogen atmosphere. Three vial strengths (40mg, 125mg, 500mg) are manufactured under separately validated processes at our facility.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (<0.06 EU/mg for 40mg; <0.03 EU/mg for 125mg and 500mg) · Appearance of lyophilised cake · Reconstitution time and clarity · pH of reconstituted solution (7.0–8.0) · Assay by HPLC (90.0–110.0%) · 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.