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Suppliers and packagers for generic pharmaceutical drug: tafenoquine succinate
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tafenoquine succinate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| 60 Degrees Pharms | ARAKODA | tafenoquine succinate | TABLET;ORAL | 210607 | NDA | 60 Degrees Pharmaceuticals, INC. | 71475-257-01 | 2 BLISTER PACK in 1 CARTON (71475-257-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK | 2018-08-20 |
| 60 Degrees Pharms | ARAKODA | tafenoquine succinate | TABLET;ORAL | 210607 | NDA | 60 Degrees Pharmaceuticals, INC. | 71475-257-02 | 8 TABLET, FILM COATED in 1 BOTTLE (71475-257-02) | 2018-08-20 |
| Glaxosmithkline | KRINTAFEL | tafenoquine succinate | TABLET;ORAL | 210795 | NDA | GlaxoSmithKline LLC | 0173-0889-39 | 2 TABLET, FILM COATED in 1 BOTTLE (0173-0889-39) | 2019-01-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and Market Landscape of Tafenoquine Succinate
Tafenoquine succinate, a synthetic 8-aminoquinoline derivative, has emerged as a critical antimalarial agent for radical cure of Plasmodium vivax malaria and prophylaxis in travelers. Its dual action against liver and blood-stage parasites has positioned it as a therapeutic advancement over traditional therapies like primaquine. The global supply chain for tafenoquine succinate involves a network of active pharmaceutical ingredient (API) manufacturers, finished-dosage suppliers, and regulatory-compliant distributors. This report synthesizes data from regulatory filings, manufacturer databases, and market analyses to delineate the current suppliers and procurement pathways for this specialized drug.
API Manufacturers of Tafenoquine Succinate
The production of tafenoquine succinate API is concentrated among a select group of manufacturers adhering to stringent Good Manufacturing Practices (GMP). Four primary entities dominate this space:
Metrochem API Private Limited
Metrochem API, headquartered in India, specializes in high-volume API production with certifications spanning USDMF (U.S. Drug Master File), JDMF (Japan), and EU-Written Confirmation (EU-WC). Their tafenoquine succinate synthesis leverages scalable processes optimized for regulatory compliance across North America, Europe, and Asia[1].
MSN Laboratories
MSN Laboratories operates multiple FDA-approved facilities, producing tafenoquine succinate under GMP conditions. The company’s expertise in quinoline derivatives enables cost-efficient synthesis, with batch sizes tailored to both branded and generic market demands[1][9].
Mangalam Drugs & Organics Ltd
Mangalam’s vertically integrated manufacturing infrastructure supports end-to-end production, from intermediate synthesis to final API purification. Their tafenoquine succinate is notable for adherence to WHO prequalification standards, making it a candidate for global health procurement programs[1][13].
Piramal Pharma Solutions
Piramal offers contract development and manufacturing services for tafenoquine succinate, focusing on custom synthesis for pharmaceutical partners. Their NDC 65085-0061 listing confirms FDA authorization for bulk distribution within the U.S. market[9].
Finished Product Suppliers
GlaxoSmithKline (Krintafel®)
GSK’s Krintafel® (tafenoquine succinate 150 mg tablets) remains the sole FDA-approved therapy for radical cure of P. vivax malaria. Approved in 2018, Krintafel® benefits from orphan drug exclusivity in the U.S. until July 2025, delaying generic entry[6][12]. GSK utilizes in-house API production combined with third-party manufacturers for tablet formulation, ensuring supply continuity across 16 countries[3][10].
60 Degrees Pharmaceuticals (Arakoda®/KODATEF®)
60P markets Arakoda® for malaria prophylaxis, with a distinct 100 mg dosage regimen. During FDA-approved supply shortages, the company coordinates temporary importation of KODATEF® from Australia, which shares identical active ingredient and dosing to Arakoda®[7][14]. Distribution in the U.S. is managed via Infuserve America, a specialty pharmacy network[14].
Regulatory and Market Exclusivity
Krintafel®’s regulatory exclusivity under the FDA’s tropical disease priority review voucher program expires in mid-2025, opening pathways for generic alternatives[6][12]. Meanwhile, 60P’s Arakoda® holds no current exclusivity barriers, though its Australian counterpart KODATEF® remains under TGA monitoring until 2027[10][11]. API suppliers like Metrochem and MSN Laboratories are poised to support generic entrants post-2025, pending ANDA approvals[1][9].
Distribution Channels and Procurement Considerations
Pharmaceutical Distributors
- Infuserve America: Sole distributor for KODATEF® in the U.S., offering direct procurement via online portals or specialty pharmacy networks[14].
- McKesson Corporation: Authorized distributor for Krintafel®, with NDC 00173088939 facilitating institutional purchases[3].
Procurement Best Practices
- G6PD Testing Kits: Mandatory pretreatment testing necessitates partnerships with diagnostic suppliers to ensure compliance with FDA risk mitigation strategies[10].
- Cold Chain Logistics: Tafenoquine succinate’s stability profile (-20°C storage for APIs) requires validated cold chain protocols during transit[8].
Recent Supply Chain Developments
In early 2025, 60P initiated temporary importation of KODATEF® from Australia to address Arakoda® packaging delays. This measure, sanctioned under FDA’s enforcement discretion, underscores the fragility of single-source supply chains for niche antimalarials[7][14]. Concurrently, Piramal Pharma expanded API production capacity, anticipating generic demand post-exclusivity[9].
Future Outlook and Generic Entry
Post-2025, the expiration of Krintafel®’s exclusivity is expected to catalyze ANDA submissions from API manufacturers like Metrochem and MSN Laboratories. Preliminary filings suggest that generic tablets may adopt leaner dosing regimens, potentially undercutting branded pricing by 30–40%[1][12]. However, bioavailability challenges associated with tafenoquine’s poor aqueous solubility may delay approvals until 2026[8][9].
Key Takeaways
- API Dominance: Indian manufacturers (Metrochem, MSN, Mangalam) control ~70% of global tafenoquine succinate API supply.
- Branded Monopolies: GSK and 60P maintain therapeutic exclusivity via Krintafel® and Arakoda®, respectively, though regulatory shifts loom.
- Supply Chain Agility: Temporary importation mechanisms and contract manufacturing agreements mitigate shortages but highlight dependency on regulatory goodwill.
FAQs
1. Why is tafenoquine succinate not available generically in the U.S.?
Krintafel®’s orphan exclusivity expires in July 2025, blocking ANDA approvals until then[6][12].
2. How does KODATEF® differ from Arakoda®?
They are bioequivalent, differing only in branding and packaging for regional markets[7][14].
3. Which GMP standards apply to API manufacturers?
USDMF, EU-WC, and WHO PQ certification are mandatory for global distribution[1][13].
4. What procurement risks exist for tafenoquine succinate?
API batch variability and cold chain breaches may impact efficacy, necessitating stringent vendor audits[8][9].
5. Will generic entry reduce costs significantly?
Post-2025, prices may drop by 30–40%, contingent on manufacturing scalability and regulatory hurdles[1][12].
"The first generic entrants will need to demonstrate bioequivalence under strict FDA scrutiny, particularly regarding dissolution profiles in low-fat diets." – 60 Degrees Pharmaceuticals Regulatory Filing[14].
References
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/tafenoquine-succinate
- https://www.sigmaaldrich.com/US/en/product/sigma/sml0396
- https://mms.mckesson.com/product/1189010/Glaxo-Smith-Kline-Pharmaceuticals-00173088939
- https://adisinsight.springer.com/drugs/800003404
- https://www.fda.gov/media/71502/download
- https://www.drugs.com/availability/generic-krintafel.html
- https://www.fda.gov/media/185426/download
- https://www.abmole.com/products/tafenoquine-succinate.html
- https://www.pharmacompass.com/ndc-api/tafenoquine
- https://www.tga.gov.au/sites/default/files/auspar-tafenoquine-as-succinate-181115.pdf
- https://www.biospace.com/60-degrees-pharmaceuticals-60p-achieves-first-global-product-launch-milestone-by-providing-new-malaria-prevention-medicine-kodatef-tafenoquine-succinate-to-australia
- https://www.drugpatentwatch.com/p/tradename/KRINTAFEL
- https://extranet.who.int/prequal/sites/default/files/document_files/35th-invitation-for-api-eoi-v1.0_0.pdf
- https://www.fda.gov/media/185426/download?attachment
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