Suppliers and packagers for generic pharmaceutical drug: ASCORBIC ACID

ASCORBIC ACID

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mcguff	ASCOR	ascorbic acid	SOLUTION;INTRAVENOUS	209112	NDA	McGuff Pharmaceuticals, Inc.	67157-101-50	1 VIAL, GLASS in 1 CARTON (67157-101-50) / 50 mL in 1 VIAL, GLASS	2018-01-15
Mcguff	ASCOR	ascorbic acid	SOLUTION;INTRAVENOUS	209112	NDA	McGuff Pharmaceuticals, Inc.	67157-101-51	25 VIAL, GLASS in 1 TRAY (67157-101-51) / 50 mL in 1 VIAL, GLASS	2018-01-15

Suppliers for the Pharmaceutical Drug: Ascorbic Acid

Last updated: August 6, 2025

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Introduction

Ascorbic acid, commonly known as vitamin C, is a critical compound in pharmaceutical formulations, nutritional supplements, and clinical treatments. Its widespread applications in healthcare demand a reliable, compliant, and high-quality supply chain. This article offers a comprehensive overview of global suppliers for pharmaceutical-grade ascorbic acid, examining their manufacturing capabilities, geographical distribution, regulatory compliance, and market positioning.

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Global Landscape of Ascorbic Acid Suppliers

Major Production Regions

The primary production zones for pharmaceutical-grade ascorbic acid include China, India, Europe, and North America. China dominates the market, accounting for over 70% of global production due to cost advantages and established manufacturing infrastructure.

• China: Home to leading manufacturers like Kangcare Biotech, Meihua Group, and Hubei Linglong Biotech, China leverages its extensive industrial base to produce large volumes of pharmaceutical-grade ascorbic acid with stringent quality standards applicable to export markets.

• India: Companies such as Roha Dyechem and Qualichem are key Indian suppliers, focusing on quality compliance and cost-effective production tailored to pharmaceutical and nutraceutical segments.

• Europe & North America: These regions host specialized manufacturers emphasizing compliance with regulatory standards like the European Pharmacopoeia (EP) and the US Pharmacopeia (USP). Notables include DSM Sinochem Pharmaceuticals (Netherlands) and Sigma-Aldrich (now a part of Merck KGaA).

Leading Suppliers and Their Capabilities

1. Meihua Group (China)

   • Overview: One of the world's largest producers, Meihua's facilities meet global GMP standards.
   • Certifications: ISO 9001, FS 22000, and GMP.
   • Market Focus: Supplies pharmaceutical, cosmetic, and food-grade ascorbic acid globally.

2. Hubei Linglong Biotech (China)

   • Overview: Specializes in high-purity pharmaceutical-grade ascorbic acid.
   • Certifications: EC GMP, ISO 9001.
   • Strengths: Strong R&D focus, ability to customize formulations.

3. Roha Dyechem (India)

   • Overview: Known for cost-effective manufacturing with adherence to international quality standards.
   • Market Focus: Supplies pharmaceutical and nutraceutical segments.

4. DSM Sinochem Pharmaceuticals (Netherlands)

   • Overview: Offers high-purity ascorbic acid compliant with European standards.
   • Certifications: GMP, ISO 9001, and EP/USP compliance.

5. Sigma-Aldrich (Merck Group)

   • Overview: Provides pharmaceutical-grade ascorbic acid for laboratory and manufacturing use.
   • Certifications: Pharmacopoeia-compliant products with rigorous quality control.

Emerging & Niche Suppliers

• Yunnan Panchemical (China): Focused on specialty chemical derivatives.
• Vansan Chemicals (India): Developing niche formulations like stabilized derivatives.

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Regulatory & Quality Considerations

Suppliers targeting pharmaceutical applications must comply with stringent regulatory frameworks, such as:

• Pharmacopoeia Standards: EP, USP, JP (Japanese Pharmacopoeia).
• GMP Certification: Ensures manufacturing consistency and safety.
• Certifications: ISO 9001, FSSC 22000, HALAL, and HALAL certifications for diverse markets.

Manufacturers that demonstrate transparency, rigorous testing, and batch-to-batch consistency typically position ahead in procurement decisions.

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Supply Chain Dynamics and Market Trends

The supply of pharmaceutical ascorbic acid is influenced by factors including:

• Raw Material Availability: The primary raw material—glucose—must be sourced reliably. China’s capacity for integrated glucose and ascorbic acid manufacturing provides advantages.
• Environmental Regulations: Suppliers adapting to stricter environmental standards (e.g., China's new emissions controls and European environmental policies) may impact production costs.
• Trade Policies & Tariffs: Ongoing trade tensions, especially between China and Western countries, can influence import/export tariffs, impacting cost and supplier choices.
• Innovation: Suppliers investing in stabilized derivatives and bio-based production methods cater to emerging markets demanding cleaner, natural formulations.

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Evaluating a Supplier for Pharmaceutical-grade Ascorbic Acid

When selecting a supplier, procurement organizations should evaluate several criteria:

• Quality Certifications: GMP, ISO, and pharmacopoeia compliance.
• Production Capacity & Lead Time: Adequate to meet demand without disruptions.
• Cost competitiveness: Balance of price with quality.
• Traceability & Transparency: Clear documentation and batch traceability.
• Technical Support & R&D: Ability to supply customized formulations and derivatives.
• Environmental & Ethical Standards: Sustainability practices aligned with corporate social responsibility (CSR).

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Conclusion

The global market for pharmaceutical-grade ascorbic acid remains concentrated predominantly in China, with significant contributions from India and specialized suppliers in Europe and North America. Leading manufacturers like Meihua, Hubei Linglong, and DSM Sinochem have established robust, compliant supply chains capable of meeting the stringent demands of pharmaceutical companies. As regulatory standards evolve toward increased transparency and sustainability, suppliers that invest in quality assurance, transparency, and innovation will sustain a competitive advantage.

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Key Takeaways

• China dominates the pharmaceutical ascorbic acid market with its large-scale, cost-effective manufacturing.
• European and North American suppliers primarily focus on compliant, high-purity products meeting strict regulatory standards.
• Certification (GMP, ISO, pharmacopoeia adherence) is critical when sourcing for pharmaceutical applications.
• Supply chain resilience depends on raw material supply, environmental compliance, and geopolitical stability.
• Emerging derivatives and bio-based production methods represent future growth areas, demanding adaptive supplier partnerships.

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FAQs

1. What are the leading global suppliers of pharmaceutical-grade ascorbic acid?
Major suppliers include Chinese companies like Meihua Group and Hubei Linglong Biotech, Indian firms such as Roha Dyechem, and European firms like DSM Sinochem Pharmaceuticals and Sigma-Aldrich (Merck KGaA).

2. How do suppliers ensure quality compliance for pharmaceutical applications?
Suppliers adhere to Good Manufacturing Practices (GMP), obtain relevant certifications (ISO, pharmacopoeia standards), and conduct rigorous batch testing to guarantee purity, potency, and safety.

3. What factors influence the choice of an ascorbic acid supplier?
Quality certifications, manufacturing capacity, cost, regulatory compliance, supply chain reliability, and sustainability practices are primary considerations.

4. Are there environmentally sustainable sources of ascorbic acid?
Yes. Some suppliers are investing in bio-fermentation methods to produce ascorbic acid, which reduces environmental impact compared to traditional chemical synthesis.

5. How might geopolitical tensions affect the supply of pharmaceutical ascorbic acid?
Trade tariffs, export restrictions, and geopolitical disputes can disrupt supply chains, emphasizing the need for diversified sourcing and supplier qualification processes.

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References

1. [1] Market research reports from Grand View Research and IQVIA on vitamins and pharmaceuticals.
2. [2] Company websites and certifications of Meihua Group, DSM Sinochem Pharmaceuticals, Sigma-Aldrich, and others.
3. [3] European Pharmacopoeia and USP monographs for ascorbic acid.
4. [4] Industry news sources on regulatory changes and environmental standards affecting chemical manufacturing.