Bulk Pharmaceutical API Sources for VALPROIC ACID

Bulk Pharmaceutical API Sources for VALPROIC ACID

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Sigma-Aldrich		P6273_SIGMA
MP Biomedicals		206257
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Bulk Active Pharmaceutical Ingredient (API) Sources for: Valproic Acid

Last updated: July 30, 2025

Introduction

Valproic acid (VPA) is a widely utilized anticonvulsant and mood-stabilizing agent. Its applications span the treatment of epilepsy, bipolar disorder, and migraine prophylaxis. The global demand for VPA necessitates reliable bulk API sources characterized by quality, consistency, and regulatory compliance. This article examines prominent suppliers of bulk valproic acid, evaluates their market positioning, and provides insights for pharmaceutical companies seeking to secure dependable API sources.

Understanding Valproic Acid Production

Valproic acid is synthesized predominantly through chemical processes involving the degradation of valproates or via direct synthesis routes. The manufacturing requirements demand strict control over impurity profiles to adhere to regulatory standards, notably those stipulated by the FDA, EMA, and other health authorities.

Global API Suppliers for Valproic Acid

1. Jiangsu Hengrui Medicine Co., Ltd.

Overview:
A leading Chinese pharmaceutical company, Jiangsu Hengrui Medicine is renowned for its broad portfolio of APIs, including valproic acid. The company has invested heavily in Good Manufacturing Practice (GMP) facilities and rigorous quality management systems, ensuring high-quality outputs conforming to international standards.

Product Quality and Certification:
Jiangsu Hengrui's valproic acid API complies with USP and EP specifications, with consistent batch-to-batch purity exceeding 99%, and low levels of related substances. The company maintains ISO 9001, GMP, and other certifications facilitating global export.

Supply Capacity and Delivery:
With advanced manufacturing infrastructure, Hengrui offers substantial production capacity, supporting both small orders and large-volume demands. Lead times are typically 8-12 weeks, with ongoing capacity expansion.

2. Shanghai Haohui Pharmaceutical Co., Ltd.

Overview:
Specialized in fine chemicals and APIs, Shanghai Haohui operates state-of-the-art chemical synthesis facilities with a focus on neurological-active compounds.

Quality Assurance:
Their valproic acid API meets stringent quality standards, including USP, BP, and EP. The company emphasizes purity, stability, and low impurity levels, confirmed through independent testing and certificates.

Market Presence:
Haohui supplies to domestic and international markets, with exports primarily to Asia, Europe, and North America. Supply channels are well-established, ensuring timely product availability.

3. Hubei FreeTrade Chemical Industry Co., Ltd.

Overview:
A prominent Chinese API manufacturer with a diverse portfolio, including valproic acid. The company emphasizes cost-effective solutions without compromising quality.

Regulatory and Quality:
Their API products meet standards like USP, EP, and Chinese Pharmacopoeia. They maintain comprehensive documentation for regulatory submissions globally.

Production and Capacity:
Hubei FreeTrade offers flexible batch sizes, with consistent quality supplied through robust QC protocols. Lead times are generally 10-14 weeks.

4. Jubilant Life Sciences (India)

Overview:
Jubilant Life Sciences operates extensive manufacturing facilities in India and has a strong global presence. The company is known for high-quality APIn with proven regulatory acceptance.

Quality and Compliance:
Jubilant’s valproic acid APIs comply with USP, EP, and other pharmacopeias. Their manufacturing adheres to cGMP standards, and they maintain strict impurity profiles.

Supply Capabilities:
With large-scale factories, Jubilant can fulfill both large and small quantities, providing reliable supply chains to North America, Europe, and Asia.

5. Sun Pharmaceutical Industries Ltd.

Overview:
As one of India’s largest pharmaceutical firms, Sun Pharma has significant API manufacturing capacity, including valproic acid.

Quality and Certifications:
Their APIs adhere to international quality standards, with certifications from regulatory agencies. They prioritize impurity control and consistent purity.

Distribution Network:
Sun Pharma offers global distribution, ensuring timely delivery and capacity to support market demands.

Emerging and Regional API Suppliers

While large multinational companies dominate the market, several emerging suppliers, primarily based in India and China, are gaining traction by offering competitive pricing and flexible supply terms. These include companies like Qingdao Yiqing Pharmaceutical Co., Ltd. and Zhejiang Kexing Chemical Co., Ltd., which focus on cost-effective manufacturing while maintaining acceptable quality levels.

Regulatory and Quality Considerations in Sourcing API

When selecting API suppliers, quality compliance and regulatory adherence are non-negotiable. Suppliers must provide:

• Certification of GMP compliance
• Certificates of Analysis (CoA) matching pharmacopoeial standards
• Stability and impurity profile data
• Regulatory dossier support for product registration

Additionally, supplier audits and ongoing quality assessments are crucial for mitigating supply chain risks.

Conclusion

The global landscape for bulk valproic acid supply is robust, with established manufacturers primarily in China and India, complemented by regional players. Leading companies such as Jiangsu Hengrui Medicine, Jubilant Life Sciences, and Sun Pharma offer reliable quality, significant capacity, and regulatory compliance, making them prime choices for pharmaceutical developers. Emerging regional suppliers may serve as cost-effective alternatives but require diligent quality verification.

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Key Takeaways

• Market Leaders: Jiangsu Hengrui Medicine and Jubilant Life Sciences are dominant, offering high-quality API with proven regulatory track records.
• Regional Suppliers: Emerging Chinese and Indian manufacturers present cost advantages but necessitate rigorous quality assurance.
• Quality Assurance: Ensure suppliers provide GMP certification, comprehensive CoA, and impurity profiles aligning with pharmacopoeial standards.
• Supply Security: Prioritize suppliers with robust capacity and reliable delivery timelines to mitigate market disruptions.
• Regulatory Compliance: Choose suppliers with experience supporting global submissions, simplifying product registration processes.

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FAQs

1. How do I verify the quality of valproic acid APIs from different suppliers?
Verify Certificates of Analysis (CoA), GMP compliance certificates, and perform or review independent testing reports on purity and impurities. Auditing supplier facilities also ensures adherence to quality standards.

2. Are Chinese API manufacturers compliant with international regulatory standards?
Many Chinese API producers, including Jiangsu Hengrui, follow GMP standards aligned with US FDA and EMA regulations, supported by certifications and continuous audits.

3. What are the typical lead times for bulk valproic acid orders?
Lead times typically range from 8 to 14 weeks, depending on order size, supplier capacity, and regulatory documentation readiness.

4. Can regional or emerging suppliers meet global quality requirements for valproic acid?
Yes, but due diligence is necessary. Suppliers with established certifications and quality records can meet international standards; otherwise, third-party assessments are advised.

5. What factors influence the choice of a valproic acid API supplier?
Quality, regulatory compliance, capacity, lead times, cost, and the supplier’s reputation are critical factors influencing sourcing decisions.

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References

[1] U.S. Pharmacopeia. Valproic acid monograph, USP.
[2] European Pharmacopoeia. Valproic acid monograph, EP.
[3] Jiangsu Hengrui Medicine Co., Ltd. Official site.
[4] Jubilant Life Sciences. API product profiles.
[5] Sun Pharmaceutical Industries Ltd. API manufacturing data.