FOLIC ACID: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	FOLIC ACID	folic acid	INJECTABLE;INJECTION	089202	ANDA	Fresenius Kabi USA, LLC	63323-184-10	1 VIAL, MULTI-DOSE in 1 CARTON (63323-184-10) / 10 mL in 1 VIAL, MULTI-DOSE	2000-09-05
Xgen Pharms	FOLIC ACID	folic acid	INJECTABLE;INJECTION	202522	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-1100-1	1 VIAL, MULTI-DOSE in 1 CARTON (39822-1100-1) / 10 mL in 1 VIAL, MULTI-DOSE	2019-11-17
Aiping Pharm Inc	FOLIC ACID	folic acid	TABLET;ORAL	091145	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8502-05	15 TABLET in 1 BLISTER PACK (0615-8502-05)	2023-07-10
Aiping Pharm Inc	FOLIC ACID	folic acid	TABLET;ORAL	091145	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8502-07	7 TABLET in 1 BLISTER PACK (0615-8502-07)	2023-07-10
Aiping Pharm Inc	FOLIC ACID	folic acid	TABLET;ORAL	091145	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8502-39	30 TABLET in 1 BLISTER PACK (0615-8502-39)	2023-07-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Folic acid, a synthetic form of folate, is a vital B-vitamin (vitamin B9) widely utilized in nutritional supplements, fortified foods, and pharmaceutical formulations. Its significance in preventing neural tube defects during pregnancy and addressing deficiencies related to anemia underscores the demand for high-quality, reliable suppliers within global markets. As a key player in reproductive health and preventive medicine, the pharmaceutical supply chain for folic acid is intricate, comprising manufacturers across continents, each with unique regulatory, quality, and production capabilities. This comprehensive analysis provides an overview of leading suppliers, sourcing strategies, and the current landscape of the folic acid supply chain.

Global Manufacturing Landscape of Folic Acid

The production of folic acid involves complex chemical synthesis processes, with key manufacturing hubs distributed across Asia, Europe, and North America. Major producers often operate under stringent Good Manufacturing Practices (GMP) compliant facilities, ensuring product quality and regulatory acceptance.

Asia: The Leading Producer Market

Asia dominates the global supply chain, with China and India emerging as predominant manufacturers of synthetic folic acid. Chinese manufacturers benefit from scale efficiencies and cost advantages; India boasts a robust pharmaceutical industry specializing in bulk active pharmaceutical ingredients (APIs).

China: The country accounts for a significant portion of global folic acid production, with companies such as Zhejiang Yinuo Pharmaceutical and Jiangsu HengXu Pharmaceutical producing both APIs and finished dosage forms. Regulatory compliance with the Chinese Food and Drug Administration (CFDA) and adherence to international standards contribute to their global export reach.
India: Leading firms include Cadila Healthcare, biological E Limited, and Mylan Laboratories. These companies supply APIs in bulk to global pharmaceutical firms for both finished formulations and dietary supplements.

Europe and North America: High-Quality, Regulatory-Compliant Suppliers

European and North American manufacturers focus on producing high-purity folic acid APIs tailored for pharmaceutical-grade applications.

Europe: Notable companies encompass Syntor Fine Chemicals (Germany) and RECIPHARM (Sweden), emphasizing stringent quality controls aligned with EMA and FDA standards.
North America: Suppliers such as Thermo Fisher Scientific and Zhejiang Kuangda Pharmaceutical (with operations in the USA) supply high-quality folic acid suitable for regulatory approval across advanced markets.

Key Suppliers for Folic Acid

Below are some prominent suppliers recognized globally for their capacity, quality standards, and regulatory compliance:

1. Zhejiang Yinin Pharmaceutical Co., Ltd. (China)

Product Scope: Bulk API production of folic acid, intermediates, and finished pharmaceutical formulations.
Strengths: Large-scale manufacturing, GMP-certified facilities, competitive pricing.
Market Position: Among the top Chinese exporters, servicing Asia, Africa, and increasingly global markets.

2. Zhejiang Kuangda Pharmaceutical Co., Ltd. (China)

Product Scope: API manufacturing with certifications for global pharmaceutical markets.
Strengths: Commitment to quality, competitive supply chain, ISO and GMP compliance.
Market Position: Increasing penetration in North America and Europe.

3. Mylan Laboratories (India)

Product Scope: API manufacturing and finished dosage forms, including folic acid.
Strengths: Established global footprint, high regulatory standards, extensive R&D capabilities.
Market Position: Critical supplier for generic and branded pharmaceutical companies worldwide.

4. Jiangsu Hengrui Pharmaceutical Co., Ltd. (China)

Product Scope: API and formulation development, including folic acid.
Strengths: Innovation-driven, high-quality standards, compliant with international regulatory frameworks.
Market Position: Expanding global reach, especially in personalized medicine segments.

5. Thermo Fisher Scientific (United States)

Product Scope: Commercial supplier of pharmaceutical-grade APIs, including high quality folic acid.
Strengths: Strong regulatory compliance, global distribution network, and extensive quality assurance systems.
Market Position: Serving pharmaceutical, biotech, and research institutions.

6. DSM (Netherlands)

Product Scope: Specialty chemicals and active ingredients including folic acid.
Strengths: Focus on sustainability, innovation, and clean manufacturing processes.
Market Position: Premium supplier for pharmaceutical and fortification industries.

7. Zhejiang Biokangtai Co., Ltd. (China)

Product Scope: API manufacturing, with a diverse portfolio including folic acid.
Strengths: Certified GMP, competitive pricing, extensive export network.
Market Position: Significant contributor to the global supply of raw materials for prenatal vitamins.

Sourcing Strategies in the Folic Acid Supply Chain

To optimize supply chain resilience and ensure regulatory compliance, pharmaceutical companies typically employ diverse sourcing strategies:

Dual-Sourcing: Engaging multiple suppliers across regions, primarily to mitigate geopolitical, quality, or supply disruptions.
Vertical Integration: Some firms invest in or acquire raw material manufacturers to control quality and costs directly.
Supplier Qualification and Audit: Rigorous vetting, including c-GMP audits, to ensure compliance with international standards.
Long-term Contracts: Establishing supply agreements to secure pricing stability and priority allocation.

Regulatory Considerations and Quality Standards

Manufacturers must meet stringent regulatory standards for APIs, including:

GMP compliance: Ensures manufacturing quality, batch consistency, and safety.
Regulatory approvals: Suppliers should possess certifications such as ISO 9001, CE, or c-GMP accreditation.
Traceability and documentation: Supporting regulatory submissions in end markets.

Failure to adhere to these standards risks supply rejections, regulatory penalties, or product recalls, emphasizing the importance of supplier due diligence.

Emerging Trends in Folic Acid Supply

Sustainable Manufacturing: Increased focus on eco-friendly synthesis processes and lower carbon footprints, aligning with ISO 14001 standards.
Quality Innovation: Enhanced purity profiles and stable formulations suitable for high-risk populations such as pregnant women.
Regional Expansion: Suppliers expanding capacities in Africa and Southeast Asia to meet rising local demands.

Conclusion

The folic acid supply landscape is characterized by a handful of key regional players with diverse capabilities and compliance standards. Asia, particularly China and India, dominate bulk API production due to cost efficiencies and scalable manufacturing capacity. European and North American suppliers primarily offer high-quality, regulatory-compliant APIs for pharmaceutical applications. Businesses sourcing folic acid must prioritize supplier qualification, quality assurance, and strategic diversification to mitigate risks associated with supply disruptions, regulatory changes, and market demands.

Key Takeaways

Leading folic acid suppliers are predominantly based in China and India, offering cost-effective bulk APIs.
European and North American manufacturers focus on high-quality, regulation-compliant APIs suitable for advanced markets.
Effective sourcing requires stringent supplier vetting, diversified supply chains, and long-term strategic relationships.
Quality standards such as GMP, ISO, and c-GMP are critical for regulatory acceptance and product safety.
Emerging trends prioritize sustainability, purity, and regional capacity expansion to meet growing global demands.

FAQs

1. What are the primary regions supplying pharmaceutical-grade folic acid?
China, India, Europe, and North America are the primary regions, with China and India leading in bulk API production and Europe and North America focusing on high-quality, regulatory-compliant APIs.

2. How do suppliers differ in quality standards?
Chinese and Indian suppliers often compete on price and volume, whereas European and North American suppliers emphasize strict regulatory compliance (GMP, ISO), quality assurance, and traceability.

3. What factors should companies consider when selecting a folic acid supplier?
Manufacturing capacity, regulatory compliance, quality certifications, lead times, pricing, and supply chain stability.

4. Are there emerging markets for folic acid supply?
Yes. Africa and Southeast Asia are experiencing growing demand, prompting suppliers to expand regional capacities and adapt manufacturing practices accordingly.

5. How can companies mitigate supply chain disruptions for folic acid?
By engaging dual-sourcing strategies, establishing long-term contracts, conducting periodic supplier audits, and monitoring regulatory changes across different markets.

Sources

[1] European Medicines Agency. (2021). Active Substance Master File (ASMF) Guidelines.
[2] US Food and Drug Administration. (2019). Good Manufacturing Practice (GMP) Regulations.
[3] World Health Organization. (2020). Essential Medicines List: Folic Acid.
[4] Market Research Future. (2022). Global Folic Acid Market Analysis.
[5] International Pharmaceutical Regulators Forum (IPRF). (2021). API Manufacturing Standards and Certifications.

Suppliers and packagers for generic pharmaceutical drug: FOLIC ACID

FOLIC ACID

Suppliers for the Pharmaceutical Drug: Folic Acid