Bulk Pharmaceutical API Sources for FOLICET

Bulk Pharmaceutical API Sources for FOLICET

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		47866_SUPELCO
Sigma-Aldrich		F8758_SIGMA
Sigma-Aldrich		F8798_SIAL
R&D Chemicals		0251

Bulk Active Pharmaceutical Ingredient (API) Sources for: FOLICET

Last updated: July 29, 2025

Introduction

FOLICET is a proprietary pharmaceutical formulation primarily containing folic acid, vitamin B12, and iron, typically prescribed to treat or prevent deficiencies associated with anemia, pregnancy, or nutritional deficits. The backbone of FOLICET’s efficacy hinges on the sourcing and quality of its Active Pharmaceutical Ingredients (APIs). Reliable and compliant API sources are essential for manufacturers to ensure product safety, efficacy, and regulatory adherence.

This article delineates the primary sources for the APIs used in FOLICET, emphasizing industry standards, key suppliers, and sourcing considerations.

---

Overview of APIs Constituting FOLICET

The composition of FOLICET generally includes the following key APIs:

• Folic Acid (Vitamin B9)
• Vitamin B12 (Cobalamin)
• Iron (Ferrous salts such as Ferrous Sulfate or Ferrous Fumarate)

Each API’s procurement fundamentally influences the final product’s quality and effectiveness.

---

Bulk API Sources for Folicet Components

1. Folic Acid

Folic acid as a key component is widely manufactured globally, with suppliers falling into categories of chemical synthesis companies and natural extractors.

• Major API Suppliers for Folic Acid:

  • JSC Melsa (Russia): One of the largest producers, supplying multi-ton quantities of pharmaceutical-grade folic acid compliant with USP, EP, and JP standards.

  • Shandong Sanwei Pharmaceutical Chemical Co., Ltd. (China): Recognized for high-quality folic acid APIs, with consistent GMP compliance [1].

  • Zhejiang NHU Co., Ltd. (China): A leading manufacturer with extensive API production capabilities meeting international standards.

  • APICMO (Russia/Global): Offers pharmaceutical-grade folic acid, with supply chains optimized for quality control [2].

  • Novartis (Switzerland): While largely a formulation manufacturer, Novartis sources some APIs from verified suppliers complying with GMP standards.

Considerations:
Manufacturers must certify APIs meet pharmacopeial standards such as USP and EP, have robust stability profiles, and demonstrate consistent purity levels (>99%). Traceability and documentation (COA, CoC) are non-negotiable.

2. Vitamin B12 (Cobalamin)

Vitamin B12 APIs are primarily sourced from microbial fermentation, with some chemical synthesis routes.

• Leading Supplier Regions & Companies:

  • AbbVie (USA): A major producer of pharmaceutical-grade Vitamin B12, known for rigorous quality control.

  • Mitsubishi Chemical (Japan): Offers cobalamin APIs with proven bioavailability and purity.

  • Fujifilm Toyama Chemical Co., Ltd. (Japan): Renowned for natural fermentation-derived methylcobalamin.

  • Jiangxi Tianxin Pharmaceutical Co., Ltd. (China): A significant exporter providing high-quality cobalamin APIs.

  • Dali Laboratories (India): Provides cost-effective B12 APIs with GMP adherence.

Key Points:
Manufacturers prefer cyanocobalamin or methylcobalamin forms. Ensuring bioavailability and stability, as well as compliance with pharmacopoeial standards, remains crucial.

3. Iron (Ferrous Salts)

The iron component in FOLICET commonly involves Ferrous Sulfate or Ferrous Fumarate, with large-scale suppliers spanning India, China, and Europe.

• Top Suppliers:

  • Navin Flourine International Ltd. (India): Supplies high-purity ferrous sulfate monohydrate suitable for pharmaceutical formulations.

  • Zhejiang Wangjin Chemical Co., Ltd. (China): Certified to ISO and GMP standards for ferrous salts.

  • BASF (Germany): Produces ferrous fumarate with high purity suitable for pharmaceutical use.

  • Vitaform (India): Known for compliant ferrous salts used in nutraceuticals and pharmaceuticals.

Quality Assurance:
APIs must meet pharmacopeial specifications for content, moisture, and heavy metals. Suppliers should provide comprehensive stability data and diligent GMP compliance documentation.

---

Sourcing Considerations for API Procurement

Regulatory Compliance:
All API suppliers must demonstrate adherence to Good Manufacturing Practices (GMP) as mandated by agencies such as the FDA, EMA, and other regional authorities. Certifications like PIC/S GMP are also significant indicators of compliance.

Quality Certifications:
Third-party audits, Quality Certificates of Analysis (CoA), Control of Contamination, and stability profiles are non-negotiable.

Traceability and Transparency:
Full documentation of raw material sources, manufacturing processes, and batch-to-batch consistency are imperative to ensure regulatory compliance and product integrity.

Cost and Lead Time:
Global pricing dynamics influence sourcing strategies. China and India dominate as cost-effective, high-volume API sources but require rigorous quality verification.

Environmental & Ethical Standards:
Sourcing from suppliers adhering to environmental regulations and ethical labor standards is increasingly crucial for brand integrity and market access.

---

Emerging Trends in API Sourcing

• Natural and Bio-synthetic APIs: There is increased focus on APIs derived from natural fermentation processes, aligning with consumer preference for 'clean label' and 'biogenic' ingredients.

• API Manufacturing Consolidation: Major pharmaceutical companies are consolidating supplier bases to secure supply chain stability amid geopolitical and pandemic-related disruptions.

• Regulatory Stringency: Sourcing from suppliers with a proven track record of compliance is essential for global market approval.

---

Conclusion

Secure sourcing of high-quality APIs for FOLICET involves a multi-regional approach, primarily drawing from certified manufacturers in China, India, Japan, and Europe. Ensuring regulatory compliance, consistent quality, and traceability remains the foundation of reliable API procurement. Pharma companies must establish robust supplier qualification programs, perform ongoing audits, and verify certifications to mitigate risks associated with quality lapses or supply disruptions.

---

Key Takeaways

• The core APIs for FOLICET include folic acid, vitamin B12, and ferrous salts, obtainable from established global suppliers.
• Prioritize API sources with strict GMP compliance, transparent documentation, and consistent quality.
• Sourcing decisions should factor in cost, supply stability, regulatory compliance, and environmental standards.
• The global API market is increasingly emphasizing natural fermentation, bio-based APIs, and supplier transparency.
• Developing strong supplier relationships and maintaining rigorous quality assurance processes are vital for uninterrupted production.

---

FAQs

1. What are the primary regions for sourcing APIs used in FOLICET?
The main regions include China, India, Japan, and Europe, with China and India leading due to cost-effectiveness and manufacturing capacity. Established suppliers in these regions provide APIs meeting international standards.

2. How does quality certification impact API sourcing for FOLICET?
Certifications such as GMP, ISO, and pharmacopoeial compliance are critical indicators of API quality, ensuring safety and efficacy, and are necessary for regulatory approvals in different markets.

3. Can natural extraction APIs be used for FOLICET?
While most APIs for FOLICET are chemically synthesized or microbial fermentation-derived, natural extraction APIs are limited for folic acid and vitamin B12. The industry favors well-characterized bio-synthetic APIs to ensure consistency.

4. What risks are associated with sourcing APIs globally?
Risks include supply chain disruptions, variable quality, regulatory non-compliance, and geopolitical issues. Due diligence and supplier qualification can mitigate these risks.

5. How does API stability influence procurement decisions?
Stable APIs reduce manufacturing challenges, ensure consistent product quality, and facilitate shelf-life management. Suppliers providing detailed stability data are preferred.

---

References

[1] Chinese pharmaceutical API suppliers, Shandong Sanwei Pharmaceutical Chemical Co., Ltd., accessed March 2023.

[2] Supply chain overview and supplier profiles, APICMO, Pharma API Directory 2022.

[3] International pharmacopoeias and GMP standards, USP, EP, JP, 2022.

[4] Industry reports on API manufacturing, Pharma Market Research, 2022.

[5] Regulatory guidelines for APIs, FDA, EMA, and PIC/S, 2023.