Bulk Pharmaceutical API Sources for NIRAPARIB TOSYLATE

Bulk Pharmaceutical API Sources for NIRAPARIB TOSYLATE

Vendor	Vendor Homepage	Vendor Sku	API Url
AbaChemScene		CS-2283
MedChemexpress MCE		HY-10619B
OXCHEM CORPORATION		AX8326059
BePharm Ltd.		B326059

Bulk Active Pharmaceutical Ingredient (API) Sources for Niraparib Tosylate

Last updated: July 30, 2025

Introduction

Niraparib tosylate, marketed as Zejula, is a selective poly(ADP-ribose) polymerase (PARP) inhibitor indicated primarily for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer responding to platinum-based chemotherapy. The pharmaceutical industry’s reliance on high-quality API sourcing is critical—directly impacting drug efficacy, safety, and regulatory compliance. This comprehensive analysis evaluates the global API procurement landscape for Niraparib Tosylate, emphasizing credible suppliers, manufacturing capabilities, quality standards, regulatory statuses, and market dynamics.

Understanding Niraparib Tosylate

Niraparib’s molecular formula is C25H29N3O4S, with a molecular weight of approximately 463.59 g/mol. The tosylate salt enhances compound stability and solubility, facilitating formulation. The synthesis of Niraparib tosylate involves complex multi-step organic reactions, necessitating stringent quality controls and high-purity manufacturing. Since its initial approval by the FDA in 2017, multiple generic and branded versions have surfaced, fueling the demand for reliable API sources.

Global API Manufacturing Landscape

Major API-Producing Countries

The supply of Niraparib Tosylate largely hinges on key pharmaceutical manufacturing hubs, notably:

• India: Leading in generic API production with established plants compliant with WHO-GMP and US FDA standards.
• China: Increasing API manufacturing capacity, often focusing on cost-effective bulk production.
• Europe and North America: Fewer manufacturers; primarily perform formulation and final drug manufacturing, with some specialty API producers.

Key API Manufacturers and Suppliers

1. Dr. Reddy’s Laboratories (India)

   • A globally recognized API manufacturer with extensive experience in oncology APIs.
   • Capable of producing Niraparib Tosylate with high purity standards suitable for global markets.
   • Possesses US FDA, EU GMP, and other regulatory certifications.

2. Divi’s Laboratories (India)

   • Known for synthesizing complex molecules, including targeted therapies.
   • Maintains rigorous quality controls, with capacity to supply large quantities of Niraparib-related APIs.
   • Compliant with international quality standards.

3. Sun Pharmaceutical Industries (India)

   • Focuses on large-scale API manufacturing with export capabilities.
   • Engages in continuous capacity expansion, emphasizing process optimization for Niraparib intermediates and salt forms.

4. Hainan Hong Li Chemical Co., Ltd. (China)

   • Specialized in manufacturing various API salts and intermediates.
   • Offers competitive pricing with compliance to international regulatory standards, although regulatory validation may vary.

5. CordenPharma (Europe)

   • Provides custom synthesis and high-quality APIs for oncology drugs.
   • Offers reliable sourcing options, especially for GMP-compliant Niraparib API.

6. Mitsubishi Gas Chemical Co., Inc. (Japan)

   • Supplies Tosyl chloride, a precursor for tosylate salts, indirectly supporting Niraparib Tosylate synthesis specifications.

Regulatory Considerations

Drug manufacturers and API buyers prioritize suppliers with current cGMP compliance, validated manufacturing processes, and rigorous quality control protocols. Regulatory clearance via authorities such as the US FDA, EMA, and PMDA ensures market legitimacy and quality assurance. Many Indian and Chinese API suppliers have achieved such certifications, making them preferred choices for global pharmaceutical companies.

Supply Chain Dynamics

The current API supply chain for Niraparib Tosylate faces challenges including:

• Regulatory Stringency: Increasing requirements for documentation, process validation, and batch testing.
• Capacity Constraints: Growing global demand has prompted expansion but also led to occasional shortages and lead time variability.
• Pricing Fluctuations: Cost pressures drive manufacturers to optimize economies of scale without compromising quality.
• Geopolitical Factors: Tariffs, trade disputes, and regional regulatory policies influence international sourcing strategies.

Quality and Certification Standards

Major API suppliers adhere to certifications such as:

• GMP (Good Manufacturing Practice)
• FDA Drug Master File (DMF) registration
• European Union Good Manufacturing Practice (EU GMP) certification
• ISO certifications for quality management

Suppliers with these qualifies are favored by multinational clients seeking regulatory approval and market access.

Emerging Trends in API Sourcing

• Vertical Integration: Some pharmaceutical companies are investing in in-house API manufacturing to secure supply chains.
• Synthetic Process Innovation: Advances in green chemistry and process intensification are enhancing API purity and reducing costs.
• Regional Manufacturing Expansion: Increased capacity in India and China aims to meet the rising demand while maintaining compliance.

Conclusion

The sourcing of Niraparib Tosylate API is diversified geographically, with prominent suppliers in India, China, and Europe. Indian companies such as Dr. Reddy’s and Divi’s Laboratories lead the market due to their extensive experience in oncological API synthesis and strong regulatory compliance frameworks. Chinese suppliers offer competitive pricing but require rigorous validation for regulatory acceptance. Ensuring supply chain reliability hinges on choosing suppliers with proven GMP compliance, quality certifications, and robust production capacity.

Business decision-makers should prioritize suppliers with validated manufacturing processes, proven regulatory track records, and scalable capacities to mitigate risks tied to supply shortages and regulatory delays.

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Key Takeaways

• India dominates Niraparib Tosylate API manufacturing, with companies like Dr. Reddy’s and Divi’s Laboratories leading quality and capacity.
• Regulatory compliance (FDA, EMA GMP certifications) is critical for reliable API sourcing for global markets.
• Chinese API suppliers are emerging but require thorough validation; competitive pricing must weigh against quality assurance.
• Supply chain resilience demands diversification among multiple suppliers with proven manufacturing standards.
• Innovative process development and regional capacity expansion are shaping future API sourcing dynamics.

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FAQs

1. What are the primary considerations when sourcing Niraparib Tosylate API?
Quality certifications (GMP compliance), manufacturing capacity, regulatory track record, and price competitiveness are key factors influencing sourcing decisions.

2. Are there any fully validated, FDA-approved manufacturers for Niraparib Tosylate API?
While some Indian manufacturers hold FDA DMFs and GMP certification, full FDA-approved API suppliers are limited; many operate under approved manufacturing licenses meeting international standards.

3. How does regulatory compliance impact API sourcing for Niraparib Tosylate?
Regulatory compliance ensures product quality, reduces approval risks, and facilitates market access; non-compliance can lead to delays, increased scrutiny, or rejection from regulatory authorities.

4. What role do Chinese API manufacturers play in supplying Niraparib Tosylate?
Chinese manufacturers provide cost-effective API options, but buyers must ensure adherence to international quality standards and seek proper validation to meet regulatory requirements.

5. What emerging trends will influence future API sourcing strategies for Niraparib Tosylate?
Vertical integration, process innovation, increased regional manufacturing capacity, and stricter regulatory environments will shape sourcing strategies to improve supply security and product quality.

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Sources

1. U.S. Food & Drug Administration (FDA) Drug Master Files (DMFs)
2. Industry reports on API manufacturing capacities, 2022–2023
3. Company press releases and certification documentation from Dr. Reddy’s, Divi’s Laboratories, and Sun Pharmaceutical Industries
4. Market analysis by Pharmaceutical Technology and ICIS Chemical Business