Dexamethasone Injection Manufacturer in India

Product Details

Dexamethasone Injection — manufactured at 9M India

Product Specifications

Generic Name: Dexamethasone Sodium Phosphate
Strength: 4mg/mL (1mL ampoule) · 8mg/2mL (2mL ampoule)
Dosage Form: Solution for Injection
Route: Intravenous (IV) · Intramuscular (IM)
Container: Type I glass ampoule — 1mL · 2mL
Closure: Heat-sealed ampoule
Storage: Store below 30°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

Dexamethasone injection is one of the most widely used parenteral corticosteroids globally — with applications across cerebral oedema, allergic emergencies, severe asthma, COVID-19 (shown to reduce mortality), croup, nausea in chemotherapy, and anti-inflammatory therapy in surgical and rheumatological conditions. On the WHO Essential Medicines List. Among the highest-volume corticosteroid injectables in government tender programmes and export markets.

Enquire Now

Manufacturing & Compliance

How Dexamethasone Injection is manufactured at 9M India

Sterile cleanroom manufacture

Dexamethasone Sodium Phosphate solution prepared in Water for Injection with pH adjustment to 7.0–8.5 for chemical stability. Sterile-filtered through 0.22 micron membrane and aseptically filled into heat-sealed Type I glass ampoules under Grade A laminar airflow in classified cleanroom. Both 1mL and 2mL ampoule sizes are validated at our facility.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (<0.5 EU/mL) · pH (7.0–8.5) · Assay by HPLC (95.0–105.0%) · Related substances · Visible particulate matter · Colour and clarity — 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.