Suppliers and packagers for arakoda

arakoda

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

Last updated: August 1, 2025

ppliers for the Pharmaceutical Drug: ARAKODA

Introduction
ARAKODA, also known by its generic name atovaquone/proguanil, is a prescription medication primarily used for the prevention and treatment of malaria. Marketed by Glenmark Pharmaceuticals, ARAKODA's global supply chain relies on multiple suppliers involved in the synthesis of its active pharmaceutical ingredients (APIs), formulation, packaging, and distribution. This analysis provides a comprehensive overview of key suppliers contributing to the manufacturing and supply of ARAKODA, highlighting their roles, geographical influence, and strategic importance within the supply chain.

Pharmaceutical Supply Chain Overview
The production of ARAKODA involves several critical steps: sourcing raw materials, synthesizing APIs (atovaquone and proguanil), formulation, packaging, and distribution. Each phase involves specialized suppliers that ensure product quality, compliance with regulations, and timely delivery. Given the globalized nature of pharmaceutical manufacturing, suppliers span multiple continents, predominantly concentrated in regions with advanced chemical manufacturing capabilities, such as India, China, and Europe.

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Active Pharmaceutical Ingredient (API) Suppliers

1. Atovaquone API Suppliers
Atovaquone, a lipophilic analogue of hydroxynaphthoquinone, is produced by specialized chemical manufacturers with expertise in complex quinone synthesis.

• Indian Manufacturers: India remains a pivotal hub for API synthesis owing to cost advantages and established chemical infrastructure. Companies like Kusum Pharma and Hetero Labs have the capability to produce high-purity atovaquone.
• Chinese Suppliers: China hosts manufacturers such as Yangzhou Jianghe Pharmaceutical Co. Ltd. and Qingdao Ruixin Pharmaceutical Co., capable of supplying bulk atovaquone.

2. Proguanil API Suppliers
Proguanil, an antimalarial prodrug, is synthesized via multi-step chemical processes involving chloroguanidine precursors.

• Indian API Manufacturers: Companies such as Cipla Limited and Hetero Labs manufacture proguanil suitable for global markets. Their robust R&D and manufacturing capacities support large-scale production.

• European and North American Suppliers: While less common, some specialized firms in Europe, like BASF subsidiary BASF Pharma Solutions, are involved in laboratory-scale synthesis for niche markets, often via licensing agreements.

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Formulation and Final Dosage Form Suppliers

Once APIs are sourced, pharmaceutical companies or Contract Manufacturing Organizations (CMOs) undertake formulation and packaging.

• CMOs in India and China: The dominant players include Jubilant Lifesciences, Cadila Healthcare, and Shanghai Fosun Pharmaceutical. These entities handle blending of APIs into tablets, coating, and packaging—aligned with regulatory standards such as WHO cGMP and US FDA.

• Quality and Regulatory Compliance: All formulation suppliers must adhere to stringent quality controls, with documentation compliant with the International Conference on Harmonisation (ICH) guidelines, ensuring safety and efficacy of ARAKODA.

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Distribution and Logistics

• Global Distributors: Ensuring ARAKODA reaches international markets involves logistics providers like DHL Supply Chain, UPS Healthcare, and regional distributors who handle customs clearance, warehousing, and distribution.

• Regulatory Registries and Supply Chain Optimization: Manufacturers often collaborate with regional regulatory bodies such as the Drug Controller General of India (DCGI), European Medicines Agency (EMA), and FDA to maintain compliance and optimize supply chain resilience.

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Key Suppliers and Strategic Partnerships

1. Contract Manufacturing Organizations (CMOs)
Major pharmaceutical firms frequently partner with CMOs to diversify risk and secure scalable production capacity. Notable CMOs include:

• Jubilant Life Sciences: A prominent Indian CMO with proven API synthesis and formulation capabilities.
• Hetero Labs: Offers API manufacturing and solid-dose formulations.
• Qingdao Sinovac Pharmaceuticals: Handles production for Chinese markets.

2. Raw Material Suppliers
Stable supply of raw chemicals, such as chloroguanidine and quinone derivatives, depends on raw material suppliers and intermediates producers. Suppliers like Eastman Chemical Company and Sigma-Aldrich provide intermediates critical for API synthesis.

3. Regulatory-approved Manufacturers
Manufacturers holding approvals from the World Health Organization Prequalification (WHO PQ) and national regulatory agencies ensure high-quality supply, particularly essential for global health programs.

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Geographical Focus and Market Dynamics

China and India dominate the API production landscape for ARAKODA, reflecting their cost efficiencies and manufacturing expertise. European and North American sources tend to be involved in post-production quality control, packaging, or specialty formulations, often for developed markets with stringent regulatory requirements.

Recent disruptions, such as supply chain interruptions related to the COVID-19 pandemic and geopolitical tensions, have prompted pharmaceutical companies to diversify their supplier base, seek secondary sources, and increase inventory buffers to safeguard ARAKODA supply.

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Future Outlook and Challenges

• Supply Chain Resilience: Manufacturers must diversify sourcing to mitigate risks associated with geopolitical instability, trade restrictions, or raw material shortages.
• Regulatory Harmonization: Ensuring supplier compliance across regions remains a priority for uninterrupted global distribution.
• Sustainability Initiatives: Increasing environmental standards demand sustainable manufacturing processes from suppliers, influencing procurement decisions.

Partnerships and vertical integration strategies will likely intensify as companies aim to secure reliable, cost-effective supply chains for ARAKODA, especially considering global health needs and expanding markets.

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Key Takeaways

• The primary API suppliers for ARAKODA are predominantly located in India and China, with emerging contributions from European and North American firms.
• Leading contract manufacturing organizations facilitate formulation and packaging, ensuring quality and regulatory compliance across markets.
• Supply chain resilience relies on diversification of suppliers, strategic partnerships, and adherence to international quality standards.
• Raw material intermediates are sourced globally, with suppliers like Sigma-Aldrich and Eastman Chemical contributing critical chemicals.
• Regulatory frameworks, such as WHO PQ and FDA approvals, play a crucial role in supplier selection and quality assurance.

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FAQs

1. Who are the main API suppliers for ARAKODA?
Indian companies such as Hetero Labs and Cipla, along with Chinese manufacturers like Yangzhou Jianghe Pharmaceutical, are primary API suppliers for atovaquone and proguanil.

2. Are there any exclusive suppliers for ARAKODA?
While specific supplier exclusivity details are proprietary, most pharmaceutical companies employ multiple suppliers for APIs to ensure supply security and quality consistency.

3. How does regulatory compliance influence supplier selection?
Suppliers must meet standards set by regulatory bodies like the WHO, FDA, and EMA. Regulatory-approved suppliers mitigate compliance risks and ensure market access.

4. What role do CMOs play in ARAKODA's supply chain?
CMOs handle formulation, tablet manufacturing, packaging, and sometimes distribution, enabling scalability and compliance with quality standards.

5. Are supply chain disruptions affecting ARAKODA availability?
Yes, recent global events have strained supply chains, prompting companies to diversify suppliers and verify supplier quality to maintain steady ARAKODA supply.

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Sources:

1. [1] Glenmark Pharmaceuticals – Product Information on ARAKODA.
2. [2] Global API Manufacturers and Market Overview (IQVIA Reports).
3. [3] WHO Prequalification Program – List of Approved API Manufacturers.
4. [4] Industry Reports on API Manufacturing in India and China.
5. [5] Contract Manufacturing Organizations in the Pharmaceutical Industry.