Suppliers and packagers for generic pharmaceutical drug: PRIMAQUINE PHOSPHATE

PRIMAQUINE PHOSPHATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	PRIMAQUINE	primaquine phosphate	TABLET;ORAL	008316	NDA	Sanofi-Aventis U.S. LLC	0024-1596-01	100 TABLET, FILM COATED in 1 BOTTLE (0024-1596-01)	2011-04-15
Novast Labs	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	206043	ANDA	AvKARE	42291-510-01	100 TABLET, FILM COATED in 1 BOTTLE (42291-510-01)	2019-02-21
Novast Labs	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	206043	ANDA	Ingenus Pharmaceuticals, LLC	50742-191-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-01)	2018-01-23
Novast Labs	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	206043	ANDA	Ingenus Pharmaceuticals, LLC	50742-191-05	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-191-05)	2018-01-23
Unichem	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	204476	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-721-14	14 TABLET in 1 BOTTLE, PLASTIC (43063-721-14)	2014-08-01
Unichem	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	204476	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-721-28	28 TABLET in 1 BOTTLE, PLASTIC (43063-721-28)	2014-08-01

Primaquine Phosphate Suppliers: Global Landscape and Manufacturing Capabilities

Last updated: February 19, 2026

This analysis identifies key global suppliers of Primaquine Phosphate, outlines their manufacturing capabilities, and assesses the competitive environment for this antimalarial drug ingredient.

What is Primaquine Phosphate?

Primaquine Phosphate is an 8-aminoquinoline antimalarial medication. It is primarily used for the radical cure of Plasmodium vivax and Plasmodium ovale malaria and for the prophylaxis of malaria [1]. It targets dormant liver stages of the parasite, preventing relapse. The drug is on the World Health Organization's List of Essential Medicines [2].

Who Manufactures Primaquine Phosphate?

Manufacturing of Primaquine Phosphate Active Pharmaceutical Ingredient (API) is concentrated in a limited number of regions, primarily India and, to a lesser extent, China. Several companies possess the necessary synthesis capabilities and adhere to Good Manufacturing Practices (GMP) required for pharmaceutical API production.

Key Manufacturing Regions and Companies:

• India: India is a significant global producer of Primaquine Phosphate API. Several Indian pharmaceutical companies are established suppliers, leveraging their robust API manufacturing infrastructure and cost-competitiveness.

  • IOL Chemicals and Pharmaceuticals Ltd. (IOLCP): A prominent Indian manufacturer with a diverse API portfolio, including Primaquine Phosphate. IOLCP operates multiple GMP-compliant manufacturing facilities [3].
  • Alka Pharmachem: An Indian API manufacturer that lists Primaquine Phosphate in its product catalog, indicating production capabilities [4].
  • Navya Pharma Pvt. Ltd.: Another Indian entity that appears in supplier directories for Primaquine Phosphate.
  • Unique Formulations Pvt. Ltd.: Part of the Unique Group, this company is listed as a manufacturer of Primaquine Phosphate [5].

• China: While less dominant than India, Chinese manufacturers also contribute to the global supply of Primaquine Phosphate API.

  • Hubei Jusheng Technology Co., Ltd.: A Chinese chemical company that lists Primaquine Phosphate among its pharmaceutical intermediates and APIs.
  • Wuhan Fortuna Chemical Co., Ltd.: Another Chinese supplier that indicates Primaquine Phosphate production.

• Other Regions: Some API manufacturers in other regions may produce Primaquine Phosphate, but they are less frequently cited in prominent supplier lists for bulk API procurement. However, many global pharmaceutical companies rely on these primary manufacturing hubs for their supply chains.

What are the Manufacturing Capabilities and Regulatory Compliance Standards?

Manufacturers of Primaquine Phosphate API must adhere to stringent regulatory standards to ensure product quality, safety, and efficacy.

Key Manufacturing Aspects:

• Synthesis Process: The synthesis of Primaquine Phosphate involves multiple chemical steps. Manufacturers must control reaction parameters, purification processes, and impurity profiles to meet pharmacopoeial standards (e.g., USP, EP, IP).
• GMP Compliance: Facilities producing Primaquine Phosphate API must operate under current Good Manufacturing Practices (cGMP) as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others. This includes robust quality management systems, validated processes, and comprehensive documentation.
• Quality Control: Rigorous quality control testing is essential, including assays for potency, identification tests, impurity profiling (related substances, residual solvents), and physical characteristics.
• Regulatory Filings: Manufacturers often hold or are working towards Drug Master Files (DMFs) or Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) to support customer regulatory submissions in various markets.
• Capacity: Manufacturing capacity varies among suppliers. Key Indian manufacturers often possess large-scale production capabilities to serve both domestic and international markets.

What is the Supply Chain Landscape for Primaquine Phosphate?

The supply chain for Primaquine Phosphate API is characterized by a concentration of manufacturers, primarily in India. This concentration can present both opportunities and risks for pharmaceutical companies sourcing the API.

Supply Chain Dynamics:

• API Suppliers: Direct manufacturers of Primaquine Phosphate API are the primary nodes in the supply chain. These are typically large to medium-sized chemical and pharmaceutical companies.
• Distributors and Traders: Pharmaceutical ingredient distributors and API trading companies also play a role, facilitating the movement of API from manufacturers to formulators, especially for smaller quantities or in regions where direct sourcing is less common.
• Formulators: Companies that develop and manufacture the finished dosage forms (tablets) are the end-users of the API. They source Primaquine Phosphate from API manufacturers or distributors.
• Geographic Concentration: The heavy reliance on India for API production means that global supply is significantly influenced by the Indian pharmaceutical manufacturing sector.
• Risk Factors: Potential risks include supply disruptions due to regulatory changes in India, geopolitical events, quality control issues at a major supplier, or fluctuations in raw material availability for the synthesis process.

What is the Competitive Environment for Primaquine Phosphate API?

The market for Primaquine Phosphate API is moderately competitive, with a few key players holding significant market share. Price, quality, regulatory compliance, and supply reliability are key competitive factors.

Competitive Factors:

• Price: As a generic API for an older drug, price competitiveness is crucial. Indian manufacturers often have a cost advantage due to lower manufacturing overheads and economies of scale.
• Quality and Regulatory Status: Manufacturers with strong quality systems, consistent GMP compliance, and established regulatory filings (e.g., FDA-approved DMFs, CEPs) are preferred by global pharmaceutical companies. Audits and inspections by regulatory authorities or customers are common.
• Supply Reliability: Consistent and timely delivery is critical for formulators managing their own production schedules. Suppliers with demonstrated supply chain robustness are favored.
• Technical Support: Manufacturers offering strong technical support, including detailed analytical data, impurity profiles, and assistance with regulatory documentation, can differentiate themselves.
• Market Demand: While Primaquine Phosphate is an essential medicine, its demand is specific to malaria-endemic regions and public health programs. Significant fluctuations in demand can impact the competitive landscape.

What are the Key Considerations for Sourcing Primaquine Phosphate?

Pharmaceutical companies seeking to source Primaquine Phosphate API must conduct thorough due diligence.

Sourcing Considerations:

• Supplier Audits: Conduct on-site audits of potential manufacturers to assess GMP compliance, quality systems, and manufacturing practices.
• Regulatory Documentation Review: Scrutinize DMFs, CEPs, and any other relevant regulatory filings. Verify their completeness and acceptance by target regulatory agencies.
• Quality Agreements: Establish comprehensive quality agreements with suppliers that clearly define quality standards, testing procedures, change control, and handling of deviations.
• Supply Chain Resilience: Assess the supplier's risk management strategies, including their raw material sourcing, contingency plans for production disruptions, and inventory management.
• Intellectual Property (IP): For older, off-patent APIs like Primaquine Phosphate, the primary IP concern relates to manufacturing process patents. Ensure freedom to operate.
• Long-Term Partnerships: Consider developing long-term relationships with reliable suppliers to ensure stable pricing and consistent supply.

Key Takeaways

• Primaquine Phosphate API manufacturing is concentrated, with India being the predominant global supplier.
• Key Indian manufacturers include IOL Chemicals and Pharmaceuticals Ltd., Alka Pharmachem, Navya Pharma Pvt. Ltd., and Unique Formulations Pvt. Ltd. Chinese suppliers such as Hubei Jusheng Technology Co., Ltd. also participate.
• Adherence to cGMP and robust quality control systems are paramount for all manufacturers.
• Competitive factors in the API market include price, quality, regulatory compliance (DMFs, CEPs), and supply reliability.
• Formulators must prioritize thorough supplier due diligence, including audits, regulatory document review, and establishing strong quality agreements.

FAQs

1. What are the primary pharmacopoeial standards for Primaquine Phosphate API?

Primaquine Phosphate API must comply with standards outlined in major pharmacopoeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). These monographs detail requirements for identification, assay, impurities, and other quality attributes.

2. How is supply chain risk managed for a concentrated API market like Primaquine Phosphate?

Supply chain risk can be mitigated through supplier diversification (if feasible), building strong relationships with multiple qualified suppliers, maintaining safety stock, and conducting regular risk assessments of key suppliers and their operational stability.

3. Are there any specific environmental considerations in Primaquine Phosphate API manufacturing?

Like all chemical synthesis processes, Primaquine Phosphate manufacturing involves the use of various solvents and reagents. Manufacturers are expected to comply with local and international environmental regulations regarding waste management, emissions control, and solvent recovery.

4. What is the typical lead time for sourcing bulk Primaquine Phosphate API?

Lead times can vary significantly depending on the supplier's production schedule, order volume, and current market demand. Typically, lead times can range from 8 to 16 weeks from order confirmation to delivery, but this can be shorter or longer based on specific circumstances.

5. Does the patent status of Primaquine Phosphate affect its API sourcing?

Primaquine Phosphate is a well-established, off-patent drug. This means there are no active composition-of-matter patents that would restrict its manufacturing. The primary focus for API sourcing is on manufacturing process patents and ensuring freedom to operate in that regard, alongside quality and regulatory compliance.

---

Citations

[1] World Health Organization. (2019). Guidelines for the treatment of malaria (3rd ed.). Geneva: World Health Organization.

[2] World Health Organization. (2023). World Health Organization Model List of Essential Medicines. Retrieved from https://www.who.int/publications/i/item/9789240083344

[3] IOL Chemicals and Pharmaceuticals Ltd. (n.d.). Product Portfolio. Retrieved from https://www.iolcp.com/products/apis/

[4] Alka Pharmachem. (n.d.). Products. Retrieved from https://alkapharmachem.com/products.html

[5] Unique Formulations Pvt. Ltd. (n.d.). Products. Retrieved from https://uniqueformulations.com/products/