PYRIDOXINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080618	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1410-1	1 mL in 1 VIAL (51662-1410-1)	2019-10-08
Fresenius Kabi Usa	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080618	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1410-3	25 POUCH in 1 CASE (51662-1410-3) / 1 VIAL in 1 POUCH (51662-1410-2) / 1 mL in 1 VIAL	2019-10-08
Fresenius Kabi Usa	PYRIDOXINE HYDROCHLORIDE	pyridoxine hydrochloride	INJECTABLE;INJECTION	080618	ANDA	Fresenius Kabi USA, LLC	63323-180-01	25 VIAL in 1 TRAY (63323-180-01) / 1 mL in 1 VIAL (63323-180-00)	1972-08-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Pyridoxine hydrochloride, also known as vitamin B6 hydrochloride, is a vital water-soluble vitamin used extensively in pharmaceutical formulations to treat vitamin B6 deficiency, peripheral neuropathy, and various metabolic disorders. As demand for pharmaceutical-grade pyridoxine hydrochloride continues to grow globally, identifying reliable and compliant suppliers becomes critical for pharmaceutical manufacturers, distributors, and healthcare providers.

This comprehensive overview explores the leading suppliers of pyridoxine hydrochloride, their manufacturing capacities, quality standards, geographic reach, and key considerations for procurement professionals.

Global Market Overview

The global pyridoxine hydrochloride market primarily caters to the pharmaceutical, nutraceutical, and dietary supplement sectors. Regulatory requirements in regions such as the U.S., Europe, and Asia-Pacific influence supplier selection, emphasizing Good Manufacturing Practices (GMP), purity levels, and product consistency.

Major countries producing pyridoxine hydrochloride include China, India, the United States, and certain European nations. China and India dominate the manufacturing landscape due to their large-scale chemical and pharmaceutical ingredient production capacities. Consequently, many suppliers are based in these regions, offering competitive pricing but requiring rigorous quality assurance.

Leading Suppliers of Pyridoxine Hydrochloride

1. German Remedies Pvt. Ltd.

Overview: German Remedies, though based in India, emphasizes high-quality standard production following stringent GMP guidelines and international certifications, including WHO-GMP and ISO 9001.
Capabilities: Manufacturing pharmaceutical grade pyridoxine hydrochloride with export to over 50 countries.
Product Quality: Strict adherence to pharmacopoeial specifications (USP, EP, JP). They provide batches withSpecifications typically exceeding 98% purity.
Market Position: Recognized for reliable supply chains, quality control, and competitive pricing.

2. Zhejiang Medicine Co., Ltd.

Overview: A leading Chinese manufacturer specializing in vitamins and nutraceutical ingredients.
Capabilities: Large-scale production with GMP certification, supplying bulk pyridoxine hydrochloride powder and finished formulations.
Quality Standards: Meets USP, EP, and Chinese Pharmacopoeia standards.
Distribution: Global reach with a strong presence in Asia, Europe, and North America.

3. Siloam Pharmaceuticals

Overview: An Indian pharmaceutical ingredient manufacturer emphasizing chemical synthesis and APIs.
Capabilities: Produces high-purity pyridoxine hydrochloride suitable for pharmaceutical applications.
Certifications: GMP, ISO 9001, and ISO 14001 certified, ensuring compliance with international standards.
Market Focus: Serving both generic pharmaceutical companies and dietary supplement brands.

4. Zhejiang NHU Co., Ltd.

Overview: A Chinese multinational specializing in vitamins and nutritional ingredients.
Product Portfolio: Includes pyridoxine hydrochloride with high purity grades for pharmaceutical and food applications.
Regulatory Compliance: Meets global standards including USP, EP, and Japanese Pharmacopoeia.
Supply Chain: Extensive manufacturing capacity with strict quality assurance protocols.

5. HAIKE Group

Overview: A prominent Chinese chemical and pharmaceutical ingredient provider.
Capabilities: Offers pharmaceutical-grade pyridoxine hydrochloride with consistent batch-to-batch quality.
Certifications: GMP, ISO standards, with dedicated R&D to improve product formats and formulations.
Regional Focus: Emphasizes Asian markets with growing exports to North America and Europe.

Emerging and Niche Suppliers

In addition to established giants, emerging suppliers from Southeast Asia, Eastern Europe, and Latin America are increasing their market presence. These firms often leverage local raw material advantages and offer cost-effective options, provided quality certifications are verified.

Quality and Regulatory Considerations

When selecting suppliers, compliance with pharmacopeial standards (USP, EP, JP) constitutes a critical factor. Suppliers must demonstrate thorough batch testing and adherence to GMP guidelines, verified through audits and certifications. Additionally, suppliers should provide certificates of analysis (COA), stability data, and validation documentation.

Supply Chain and Logistics

Reliability in supply chain management is paramount. Key considerations include:

Lead times: Consistency in production schedules.
Storage conditions: Proper handling to prevent moisture and temperature-related degradation.
Packaging standards: Tamper-evident and contamination-free packaging aligned with pharmaceutical norms.
Regulatory dossiers: Support for regulatory submissions in different jurisdictions.

Pricing Dynamics and Market Trends

Pricing for pyridoxine hydrochloride varies based on purity levels, packaging specifications, and supply volumes. Suppliers from China and India generally offer lower-cost products but may require more exhaustive quality verification. Recent trends reflect increasing demand due to the burgeoning supplement sector and global health initiatives, prompting suppliers to expand production capacities.

Key Considerations for Procurement

Validate suppliers' certifications and compliance status.
Request comprehensive COAs and stability data.
Assess the supplier's quality management systems.
Confirm capacity to meet demand scalability.
Evaluate delivery timelines and logistical support.
Review pricing structures aligned with quality standards.

Conclusion

The market for pyridoxine hydrochloride features numerous reputable suppliers globally, with dominant manufacturing hubs in China and India. Procurement success hinges on balancing cost-efficiency with rigorous quality assurance and regulatory compliance. Large-scale, certified producers such as Zhejiang Medicine, Zhejiang NHU, and Indian firms like Siloam Pharmaceuticals represent trusted sources, while emerging suppliers offer potential cost advantages—subject to thorough vetting.

Key Takeaways

Reliable supply of pharmaceutical-grade pyridoxine hydrochloride primarily depends on adherence to international GMP standards and regulatory certifications.
Chinese and Indian manufacturers dominate the landscape, offering a wide array of options favorable to global buyers.
Quality assurance steps—including certification verification and batch testing—are critical to mitigate risks in supply chain management.
Procurement professionals should prioritize supplier transparency, logistics efficiency, and compliance documentation to ensure uninterrupted supply.
Emerging suppliers can serve as cost-effective alternatives but must undergo rigorous qualification processes.

Frequently Asked Questions (FAQs)

1. What are the main regulatory standards that suppliers of pyridoxine hydrochloride should meet?
Suppliers should comply with pharmacopeial standards such as USP, European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). Certifications like GMP, ISO 9001, and ISO 14001 are also essential indicators of quality management systems.

2. How can I verify the quality of pyridoxine hydrochloride from an overseas supplier?
Request detailed Certificates of Analysis (COA), batch release documentation, and third-party laboratory test reports confirming purity, potency, and absence of contaminants. Conduct supplier audits and consider third-party verification when feasible.

3. Are there notable differences in quality between Chinese and Indian pyridoxine hydrochloride suppliers?
Both regions have reputable manufacturers adhering to international quality standards. Variations often relate to production scale, certifications, and quality management systems. Due diligence is key regardless of the origin.

4. What are the current market pricing trends for pyridoxine hydrochloride?
Prices are influenced by raw material costs, purity specifications, and supply chain factors. Typically, Chinese and Indian suppliers offer competitive pricing, but buyers should prioritize quality and compliance over cost alone.

5. What logistical factors should be considered when sourcing pyridoxine hydrochloride globally?
Ensure supplier capacity to meet demand, confirm appropriate storage and shipping conditions, evaluate lead times, and establish clear communication channels for order tracking and delivery confirmation.

Sources

[1] Market research reports on pharmaceutical ingredients, including vitamin APIs, provide insights into industry leaders and regional manufacturing capabilities.

[2] Regulatory agency publications and pharmacopeial standards (USP, EP, JP) outline specific quality and compliance requirements for pyridoxine hydrochloride.

[3] Industry white papers and supplier catalogs offer details on certification, production capacity, and distribution networks of major manufacturers.

[4] Trade data and import-export records reveal market flows and pricing dynamics of vitamin B6 derivatives globally.

This comprehensive analysis aims to guide pharmaceutical professionals and procurement teams in identifying, evaluating, and partnering with reliable pyridoxine hydrochloride suppliers to ensure high-quality, compliant, and timely supply.

Suppliers and packagers for PYRIDOXINE HYDROCHLORIDE