Why Farbe Firma is the Top Manufacturer of Alpha Beta Arteether Injection
- Maulik Sudani
- May 16
- 5 min read
Last Updated: May 16, 2026
TL;DR: Farbe Firma Pvt Ltd is the leading WHO-GMP certified manufacturer of Alpha Beta Arteether Injection in India, supplying high-purity 75 mg/mL and 150 mg/mL sterile oily intramuscular ampoules to anti-malaria programs and private buyers across 30+ countries from its Ankleshwar, Gujarat facility.
Key Takeaways
Alpha Beta Arteether Injection (alpha,beta-arteether 75 mg/mL or 150 mg/mL) is a rapid-acting artemisinin derivative used for severe and complicated P. falciparum malaria, and Farbe Firma manufactures it under WHO-GMP and ISO 9001:2015 certified conditions.
Each batch is produced inside ISO Class 5 (Grade A) aseptic filling lines with full sesame-oil compatibility, ensuring particulate-free, sterile oily depot injections.
CTD and ACTD dossiers are available for Latin America, CIS, Africa, the Middle East, and South-East Asia - supported by a complete COA, stability data, and BMR pack.
Farbe Firma ships Alpha Beta Arteether to 30+ countries with neutral-coded export options for distributors and government-tender buyers.
Introduction
Severe falciparum malaria still claims more than half a million lives every year, and the artemisinin family remains the WHO-endorsed first line for parenteral treatment. Within that family, Alpha Beta Arteether Injection - the alpha,beta-arteether stereoisomer mixture dissolved in sterile sesame oil - is widely used across South Asia, parts of Africa, and CIS countries because of its rapid schizonticidal action, long half-life, and ability to control parasitemia within 24 hours of a single IM injection.
Selecting the right manufacturer for this molecule is not just a commercial question - it is a clinical-safety question. Oily intramuscular injectables require specialized aseptic filtration, hermetic ampoule sealing, and validated stability under tropical conditions. Farbe Firma Pvt Ltd, a WHO-GMP certified pharmaceutical injectable manufacturer based in Ankleshwar, Gujarat, India, has built one of the most reliable Alpha Beta Arteether production lines in South Asia, supplying both 75 mg/mL and 150 mg/mL strengths to public-health programs and private distributors across 30+ countries.
What Makes Alpha Beta Arteether Injection Difficult to Manufacture
Unlike water-soluble injectables, alpha,beta-arteether is highly lipophilic and must be formulated in a sterile, refined sesame-oil vehicle. This introduces three challenges that not every contract manufacturer can solve: terminal sterilisation is not feasible because of arteether's thermo-sensitivity, so the entire process must be aseptic; sesame oil filtration requires 0.22 um hydrophobic membranes validated for oil-phase throughput; and the final ampoule must remain hermetically sealed for 24 months under Zone IV-b tropical conditions.
Farbe Firma's Alpha Beta Arteether line is purpose-built for these conditions. The active is sourced from USDMF-grade Indian APIs with full impurity profiling, including the related-substance check for dihydroartemisinin and alpha/beta stereoisomer ratio (>=30:70 by HPLC). The sterile oily solution is filtered twice through validated 0.22 um hydrophobic PVDF membranes, filled under unidirectional ISO Class 5 airflow, and sealed using rotary tip-seal ampoule machines that achieve 100% pre-filtration container-closure integrity (CCI) verification.
Strength Profile and Pack Configurations
Farbe Firma supplies Alpha Beta Arteether Injection in the two clinically dominant strengths: 75 mg/mL (1 mL ampoule) for paediatric and standard adult dosing schedules, and 150 mg/mL (2 mL ampoule) for the WHO-recommended 3-day fixed-dose regimen for adults. Standard packs are 1 x 1 mL or 1 x 2 mL amber type-I glass ampoules in printed mono-cartons, with 10 x 1's master cartons for export logistics.
Customers requesting alternative configurations - bilingual cartons (English + Spanish, English + French, English + Arabic, English + Portuguese, English + Russian), Pharmacopoeia overprints (IP/BP/USP), or country-specific batch coding for Nigeria's NAFDAC, Ghana's FDA, Bolivia's AGEMED, and similar tenders - receive validated artwork within five working days. All carton printing is done in-house on a Bobst-grade carton line to maintain pantone consistency across export shipments.
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Alpha Beta Arteether Injection manufacturer - quality and stability data
Every commercial batch of Farbe Firma's Alpha Beta Arteether Injection is released against a full CTD-aligned specification: sterility (USP <71>), bacterial endotoxins (LAL, USP <85>), assay by HPLC at 254 nm (95.0 to 105.0% of label), related substances, particulate matter (USP <788>), and CCI by dye-ingress. Long-term stability data is generated under ICH Zone IV-b conditions (30 C +/- 2 C / 65 % RH +/- 5 % RH) for 24 months in addition to 6-month accelerated (40 C / 75 % RH) data.
On the regulatory side, dossier packs are available in both CTD (Modules 1 to 5) and ACTD formats. Farbe Firma's regulatory affairs team prepares country-specific Modules 1 covering Nigeria, Kenya, Uganda, Tanzania, Bolivia, Peru, Vietnam, Cambodia, and CIS markets, including supporting documents such as the manufacturer's GMP, free-sale, ISO, and pharmacovigilance system master file (PSMF). Lead time for a full dossier hand-off is typically 2 to 4 weeks once the country and pack-size are confirmed.
Why Farbe Firma
Farbe Firma Pvt Ltd has been manufacturing sterile injectables from its Ankleshwar, Gujarat plant for more than two decades, and Alpha Beta Arteether Injection has been part of the export portfolio since the company's expansion into anti-malarial therapeutics. The facility is WHO-GMP and ISO 9001:2015 certified, with sterile filling lines built around ISO Class 5 (Grade A) aseptic cores, Grade B background, validated HVAC, and full QC laboratories on-site for HPLC, GC, LAL, sterility, and microbiology.
The company manufactures more than 100 sterile injectable molecules - covering antibiotics, anti-malarials, anaesthetics, vitamins, hormones, and corticosteroids - and exports to 30+ countries across Latin America, the CIS region, Africa, the Middle East, and South-East Asia. Buyers consistently cite Farbe Firma's responsiveness on artwork, validated stability data, and on-time export readiness as the reasons they consolidate anti-malarial procurement here.
For institutional buyers, governments, and private distributors evaluating an Alpha Beta Arteether supplier, the combination of WHO-GMP certification, ISO Class 5 aseptic processing, two-strength portfolio, complete regulatory dossier support, and a track record of zero-recall export performance makes Farbe Firma the preferred long-term partner - especially for buyers who need a reliable second source in addition to one of the larger Indian players.
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Frequently Asked Questions
Is Farbe Firma's Alpha Beta Arteether Injection WHO-GMP certified?
Yes. Every batch of Alpha Beta Arteether Injection manufactured by Farbe Firma is produced inside a WHO-GMP certified facility with ISO 9001:2015 quality systems and ISO Class 5 aseptic processing.
Which strengths and pack sizes are available?
Two strengths are routinely supplied: 75 mg/mL in 1 mL amber type-I glass ampoules and 150 mg/mL in 2 mL ampoules. Standard packs are 1 x 1's mono-carton with 10 x 1's outers, plus bilingual carton options for tender markets.
Do you provide CTD and ACTD dossiers for export registration?
Yes. Complete CTD and ACTD dossiers are available for Latin America, CIS, Africa, the Middle East, and South-East Asia, including country-specific Module 1 documents and 24-month long-term stability data under ICH Zone IV-b conditions.
What is the typical lead time for an export order?
Standard lead time after order confirmation and artwork sign-off is 30 to 45 days for first-time customers. Repeat orders ship within 25 to 30 days because artwork, dossier, and validation data are already in place.
Can Farbe Firma supply Alpha Beta Arteether Injection under our own brand?
Yes. Farbe Firma offers private-label and neutral-coded CMO supply with full artwork support, in-house carton printing, and brand-specific batch coding. Trademark registration and free-sale certificates can be coordinated with the regulatory team.
Technically Reviewed By: Maulik Sudani | Jignasu Sudani (Technical Expert)
Farbe Firma Pvt Ltd - WHO-GMP Certified Sterile Injectable Manufacturer
Website: www.farbefirma.org | Email: director@farbefirma.org
Plot No. 2818, GIDC Industrial Estate, Ankleshwar, Gujarat, INDIA
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