Do you provide CTD and ACTD dossier support for export markets?

Yes. We provide complete CTD/ACTD dossiers and product registration support for buyers across 30+ countries in Latin America, CIS, Africa, the Middle East, and South-East Asia.

Why Farbe Firma is the Top Manufacturer of Dexamethasone Sodium Phosphate Injection

Q: Is Farbe Firma WHO-GMP certified?

Yes. Farbe Firma Pvt Ltd is WHO-GMP certified, ISO 9001:2015 compliant, and operates a USFDA-aligned sterile injectable facility in Ankleshwar, Gujarat, India.

Maulik Sudani
12 hours ago
4 min read

Last Updated: May 14, 2026

TL;DR: Dexamethasone Sodium Phosphate Injection is a critical corticosteroid used worldwide for inflammation, shock, cerebral edema, and COVID-era respiratory care. Farbe Firma manufactures it at a WHO-GMP certified sterile facility in Gujarat, India, supplying CMO buyers and tender markets across 30+ countries with full CTD/ACTD dossier support.

Key Takeaways

WHO-GMP certified sterile manufacturing in Ankleshwar, Gujarat, India
Available as 4 mg/mL and 8 mg/2 mL ampoules and vials with flexible private-label packaging
Full CTD/ACTD dossier support for regulated and semi-regulated markets
Exported to 30+ countries — Latin America, CIS, Africa, Middle East, and South-East Asia

Introduction

Dexamethasone Sodium Phosphate Injection is one of the most prescribed corticosteroids in modern medicine. Listed on the WHO Model List of Essential Medicines, it is used to treat severe allergic reactions, cerebral edema, shock, croup, acute exacerbations of chronic obstructive pulmonary disease, and as an adjunct in oncology regimens. It became a globally recognized treatment for severe COVID-19 after the RECOVERY trial confirmed its mortality benefit in ventilated patients.

Because Dexamethasone Sodium Phosphate is a life-saving sterile injectable, buyers — hospital chains, government tender agencies, distributors, and CMO partners — need a manufacturer who delivers consistent purity, accurate potency, low endotoxin levels, and reliable on-time supply. Farbe Firma Pvt Ltd has built its reputation in exactly this category: producing high-volume sterile steroid injectables that meet pharmacopoeial specifications across IP, BP, and USP.

Manufacturing Excellence for Dexamethasone Sodium Phosphate Injection

Farbe Firma manufactures Dexamethasone Sodium Phosphate Injection in dedicated sterile lines that comply with WHO-GMP, ISO 9001:2015, and current Schedule M (revised) requirements. The manufacturing block uses ISO Class 5 (Grade A) laminar airflow over Class 7 (Grade B) backgrounds, with full HVAC qualification, real-time differential pressure monitoring, and gowning protocols aligned with EU Annex 1 best practices.

Active pharmaceutical ingredient (API) is sourced from audited, GMP-compliant vendors with valid DMFs and CEPs where applicable. Each incoming API batch is identity-confirmed and assay-tested against USP, BP, and IP monographs before issuance. Water for Injection (WFI) is generated in-house via multi-effect distillation and circulated at 80°C in a fully validated stainless steel loop, with twice-daily microbial and endotoxin checks.

Available Pack Sizes and Dosage Strengths

Farbe Firma supplies Dexamethasone Sodium Phosphate Injection in the strengths most demanded by global tender and CMO markets: 4 mg/mL in 1 mL or 2 mL clear glass Type-I ampoules, and 8 mg/2 mL ampoules for higher-dose indications. Multi-dose vials of 5 mL and 30 mL are available for institutional buyers who prefer a vial format with bromobutyl stopper and flip-off aluminium seal.

Private-label artwork, multilingual carton printing, regulatory-compliant inserts, batch-coded shippers, and QR-code track-and-trace serialization are available on request. Standard MOQs start at 50,000 ampoules per SKU, but we accept smaller pilot quantities for new buyers and registration batches required for dossier filing.

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Quality Control, Regulatory Support, and Global Reach

Every batch of Dexamethasone Sodium Phosphate Injection is released only after a complete QC battery: pH, assay (HPLC), related substances, identification, sterility (BP/USP membrane filtration method), bacterial endotoxins (LAL), particulate matter, and content uniformity. We retain samples for the full shelf life plus one year, and accelerated stability is run per ICH Q1A(R2) Zone IVb conditions to support hot-climate buyers.

Our regulatory affairs team prepares complete CTD dossiers (Modules 1-5) and ACTD dossiers for ASEAN buyers, including site master files, validation reports, and stability data packages. We have successfully supported product registrations in over 30 countries, with active or pending registrations in Nigeria, Kenya, Uganda, Sudan, Yemen, Cambodia, Myanmar, Honduras, Guatemala, Bolivia, and across the CIS — and our in-house team responds to deficiency letters and pharmacopoeial updates within 5 working days.

Why Farbe Firma

Farbe Firma Pvt Ltd is a WHO-GMP certified pharmaceutical manufacturer headquartered in Ankleshwar, Gujarat, India. Our purpose-built sterile injectable facility operates ISO Class 5 cleanrooms with validated HVAC, water-for-injection (WFI), and steam systems, and follows ICH Q7-Q10 lifecycle quality standards. Every batch is released after full physicochemical, microbiological, and endotoxin testing in our in-house QC laboratory.

Our portfolio spans 100+ injectables across antibiotics, anti-malarials, anaesthetics, steroids, haematinics, oncology supportives, and life-saving emergency molecules. We currently export to more than 30 countries across Latin America, the CIS, Africa, the Middle East, and South-East Asia, supporting tender supply, private-label CMO programs, and brand-development partnerships with full CTD and ACTD dossier coverage.

What differentiates Farbe Firma is the combination of regulated-market quality systems with the agility of a mid-size Indian manufacturer: short lead times, flexible MOQs, multilingual artwork, and a single-point technical liaison from RFQ to delivery. Buyers benefit from our 30+ years of collective pharma manufacturing experience and a track record of zero major regulatory observations across audits.

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Frequently Asked Questions

Is Farbe Firma WHO-GMP certified for Dexamethasone Sodium Phosphate Injection?

Yes. Our sterile injectable facility is WHO-GMP certified, ISO 9001:2015 compliant, and inspected by the Gujarat FDCA. All Dexamethasone Sodium Phosphate batches are released under these quality systems.

What strengths and pack sizes of Dexamethasone Injection do you manufacture?

We manufacture 4 mg/mL in 1 mL and 2 mL ampoules, 8 mg/2 mL ampoules, and 5 mL and 30 mL multi-dose vials. Custom strengths are evaluated on a case-by-case basis for tender requirements.

Do you provide CTD/ACTD dossiers for product registration?

Yes. Farbe Firma provides complete CTD/ACTD dossiers, site master files, validation packages, and stability data. Our regulatory team has supported registrations in 30+ countries and responds to deficiency letters within 5 working days.

What is the minimum order quantity for private-label Dexamethasone Injection?

Standard MOQs are 50,000 ampoules per SKU for full commercial production. For pilot batches and dossier filing, we accept smaller quantities — please discuss your registration timeline with our team.

How long does it take to receive a quotation?

We respond to RFQs within 24 working hours with a detailed quotation that includes price, lead time, pack-size options, artwork process, sample availability, and regulatory documentation scope.

Technically Reviewed By: Maulik Sudani | Jignasu Sudani (Technical Expert)

Farbe Firma Pvt Ltd

Website: www.farbefirma.org

Email: director@farbefirma.org

Address: Ankleshwar, Gujarat, INDIA

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