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Why Farbe Firma is the Top Manufacturer of Artemether Injection

  • Writer: Maulik Sudani
    Maulik Sudani
  • May 15
  • 4 min read

Last Updated: May 15, 2026

TL;DR: Farbe Firma Pvt Ltd is a WHO-GMP certified manufacturer of Artemether Injection in Gujarat, India, producing sterile antimalarial ampoules to ISO Class 5 standards for buyers in 30+ countries.

Key Takeaways

  • Artemether Injection 80 mg/mL is a fast-acting artemisinin-derivative used for severe and complicated falciparum malaria.

  • Farbe Firma's facility in Ankleshwar, Gujarat, manufactures Artemether Injection under WHO-GMP and ISO 9001:2015 quality systems.

  • We supply Artemether Injection ampoules with full CTD/ACTD dossier support to public-tender and private buyers across Africa, Asia, and Latin America.

  • Customizable strengths (40 mg/mL, 80 mg/mL), pack sizes, and private-label packaging are available for export markets.

Introduction

Artemether Injection remains one of the most reliable parenteral therapies for severe and complicated Plasmodium falciparum malaria, particularly in tropical regions where intravenous artesunate may not be readily available. As a lipid-soluble artemisinin derivative, artemether is administered intramuscularly and rapidly reduces parasite burden — making it indispensable for hospitals, government tenders, and humanitarian programs.

For procurement officers and CDMO partners looking for a dependable manufacturer, Farbe Firma Pvt Ltd offers a vertically integrated solution. From API-grade artemether sourcing to oil-based sterile ampoule filling and dossier support, we deliver Artemether Injection that meets WHO prequalification expectations and the regulatory dossier formats of 30+ importing countries.

Why Artemether Injection Requires Specialized Manufacturing

Unlike water-based injectables, Artemether is formulated as an oil-based solution (typically in groundnut or sesame oil) because of its low aqueous solubility. This makes the manufacturing process technically demanding: oil sterilization by dry heat, controlled sub-micron filtration of oil solutions, terminal heat sterilization protocols, and ampoule integrity testing all require dedicated equipment and validated processes.

Farbe Firma's Ankleshwar facility is purpose-built for parenteral manufacturing of both aqueous and oily formulations. We run dedicated oil-injection lines with ISO Class 5 (Grade A) aseptic core, ISO Class 7 background, and full HVAC validation. Each batch is supported by analytical release including assay, related substances by HPLC, sterility (BP/USP), bacterial endotoxin (LAL), and ampoule leak testing.

Strengths and Pack Sizes We Manufacture

We supply Artemether Injection in 40 mg/mL and 80 mg/mL strengths, with primary packaging in 1 mL clear glass ampoules (Type I borosilicate). Standard secondary packaging is 10 ampoules per carton with patient information leaflet, but we customize pack sizes — 5, 6, or 10 ampoules — to match the buyer's market preference. Multi-language artwork (English, French, Portuguese, Spanish, Arabic) is supported.

Shelf life is 24 months at controlled room temperature (below 30°C, protected from light). Stability data is generated under ICH Zone IVb conditions (30°C/75% RH long-term and 40°C/75% RH accelerated), which matches the requirements of tropical export markets including West Africa, Central Africa, and Southeast Asia.

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Regulatory Documentation We Provide

Farbe Firma supplies a complete regulatory package with every Artemether Injection shipment. The package includes a Certificate of Pharmaceutical Product (CPP), Free Sale Certificate from the FDCA Gujarat, manufacturing license, WHO-GMP certificate, and the current product registration dossier in CTD or ACTD format depending on the destination country.

For African export markets, we issue dossiers compliant with the WHO Prequalification format and the EAC, ECOWAS, and ZAZIBONA harmonized procedures. For ASEAN buyers, our ACTD dossiers include the standard Module 1 country-specific administrative documents, Module 2 quality overall summary, Module 3 full chemistry/manufacturing/control package, and Module 4-5 nonclinical/clinical references. Site master files and our valid CoPP are available immediately on request.

Quality Indicators We Track Per Batch

Beyond pharmacopoeial compliance, our quality system tracks process performance indicators on every Artemether Injection batch: bioburden before sterile filtration, environmental viable counts at the aseptic filling point, ampoule fill weight variability, terminal sterilization cycle Fo values, and seal integrity by dye penetration on 100% of ampoules in pilot batches. These data feed an annual product quality review (APQR) which we share with regulatory partners on request.

This level of process visibility is what separates a tender-grade supplier from a public-health partner. Buyers running malaria-elimination programs cannot afford a recall of antimalarial stock mid-rainy-season; our process discipline is engineered to prevent it.

Why Farbe Firma

Farbe Firma Pvt Ltd has built its reputation on producing high-quality sterile injectables for global markets. Our WHO-GMP certified facility in Ankleshwar, Gujarat, manufactures more than 100 sterile injectables — including antimalarials, antibiotics, anesthetics, antiemetics, and life-saving emergency injections. Operating ISO Class 5 cleanrooms and a dedicated oil-formulation line lets us scale Artemether Injection batches from pilot to 200,000 ampoules per shift.

Beyond manufacturing, we partner with importers as a true contract development and manufacturing organization (CDMO). We support label design, country-specific artwork, registration submissions, and post-launch lifecycle changes. Our regulatory team coordinates with the buyer's local consultant to keep dossier responses fast and dossier defects rare.

Buyers in 30+ countries — across Africa, Latin America, CIS, the Middle East, and Southeast Asia — rely on Farbe Firma for consistent supply of essential injectables. We hold an unblemished regulatory inspection track record, transparent batch documentation, and the operational discipline that public-health buyers require for malaria control programs.

Explore Farbe Firma: Products | Global Reach | About Us

Frequently Asked Questions

Is Farbe Firma's Artemether Injection WHO-GMP certified?

Yes. Artemether Injection is manufactured at our WHO-GMP certified facility in Ankleshwar, Gujarat. The site holds a valid WHO-GMP certificate issued by the FDCA, Government of Gujarat, and is ISO 9001:2015 compliant.

What strengths and pack sizes are available?

We manufacture Artemether Injection 40 mg/mL and 80 mg/mL in 1 mL ampoules. Standard pack is 10 ampoules per carton; custom pack sizes of 5 or 6 ampoules are available for tender-specific buyers.

Do you provide CTD/ACTD dossiers for registration?

Yes. We supply complete CTD dossiers for ROW markets and ACTD dossiers for ASEAN. WHO Prequalification-aligned dossiers are available for African public-health buyers and global procurement agencies such as the Global Fund partners.

What is the shelf life and storage condition?

Shelf life is 24 months at temperatures below 30°C, protected from light. Stability data is generated under ICH Zone IVb conditions to support tropical-market registration.

Can you supply Artemether Injection under our private label?

Yes. Farbe Firma supports full private-label manufacturing — your brand name, your artwork, multi-language packaging, and your country-specific MAH details on the dossier. Minimum order quantities are flexible for first registrations and pilot lots.

Farbe Firma Pvt Ltd | Gujarat, India | director@farbefirma.org | www.farbefirma.org

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