Bulk Pharmaceutical API Sources for INFUVITE PEDIATRIC

Bulk Pharmaceutical API Sources for INFUVITE PEDIATRIC

Vendor	Vendor Homepage	Vendor Sku	API Url
Specs		AC-907/25014218
Sigma-Aldrich		P5669_SIGMA
Vitas-M Laboratory		STK177324
Molport		MolPort-002-319-991

Bulk Active Pharmaceutical Ingredient (API) Sources for: INFUVITE PEDIATRIC

Last updated: August 1, 2025

---

Introduction

Infuvite Pediatric is a parenteral multivitamin and mineral supplement specifically formulated for pediatric patients. It provides essential nutrients such as vitamins A, D, E, K, B-complex, and minerals like zinc and selenium. The quality and safety of its manufacturing depend largely on the sourcing of its active pharmaceutical ingredients (APIs). Reliable sources of APIs are critical for ensuring product consistency, regulatory compliance, and patient safety. This article explores the primary bulk API sources relevant to the production of Infuvite Pediatric, emphasizing the key suppliers, regulatory benchmarks, and strategic procurement considerations.

---

Overview of API Components in Infuvite Pediatric

Infuvite Pediatric comprises multiple APIs, including but not limited to:

• Vitamins: A (Retinyl Palmitate), D3 (Cholecalciferol), E (Alpha-Tocopherol), K1 (Phytomenadione), B-vitamin complex (e.g., Thiamine, Riboflavin, Niacinamide, Pyridoxine, Cyanocobalamin, Folic Acid, Biotin)
• Minerals: Zinc sulfate, Selenium sulfide, Nicotinamide (vitamin B3)

Each component requires sourcing from reputable suppliers to guarantee potency, stability, and purity.

---

Key API Suppliers for Pediatric Multivitamins

1. Vitamin APIs

a. Vitamin A (Retinyl Palmitate):

Major suppliers of pharmaceutical-grade Vitamin A include:

• BASF SE: Offers high-purity retinyl palmitate, adhering to pharmacopeial standards (USP, EP).
• Bayer AG: Provides retinyl acetate and palmitate, with extensive regulatory documentation.
• Zhejiang NHU Biotechnology Co., Ltd.: Chinese manufacturer with global GMP certification.

b. Vitamin D3 (Cholecalciferol):

Leading providers:

• DSM Nutritional Products: Known for pharmaceutical-grade cholecalciferol with consistent bioactivity.
• CSPC Pharmaceutical Group: Chinese supplier meeting international quality standards.
• BASF: Also supplies vitamin D3 with robust dossier support.

c. Vitamin E (Alpha-Tocopherol):

Producers include:

• Evonik Industries: Supplies high-quality natural and synthetic vitamin E.
• Adisseo: Chinese manufacturer with extensive APIs for human nutrition.
• Nutritional Outlook indicates Evonik’s tocopherols are used widely in pediatric formulations.

d. Vitamin K1 (Phytomenadione):

Major sources:

• Kyowa Hakko Kirin: Japanese API supplier with high-purity vitamin K1.
• Zhejiang Medicine Co., Ltd.: Chinese manufacturer approved for pharmaceutical APIs.
• Suntory: Offers vitamin K1 with comprehensive quality documentation.

e. B-Complex Vitamins:

Suppliers:

• BASF SE: Produces pharmaceutical-grade B vitamins including Thiamine, Riboflavin, Niacinamide, Pyridoxine, Cyanocobalamin, and Folic Acid.
• DSM: Supplies various B-vitamins with GMP certification.
• China-based producers: Several recognized for their competitive pricing and quality (e.g., Hebei Yufeng Biotechnology).

2. Mineral APIs

a. Zinc Sulfate:

Leading sources:

• Tianjin Kingfull Group: A prominent Chinese API producer with ISO and GMP certification.
• SIFF Chemicals (India): Known for pharmaceutical-grade zinc sulfate.
• BASF: Supplies zinc derivatives meeting pharmacopoeial standards.

b. Selenium Sulfide:

Suppliers:

• Suzhou No. 1 Chemicals Co., Ltd.: Chinese manufacturer with high purity selenium APIs.
• AkzoNobel: Provides selenium compounds for pharmaceutical use.

---

Sourcing Considerations for API Procurement

Regulatory Compliance and Quality Assurance

API sourcing for pediatric formulations like Infuvite Pediatric necessitates strict adherence to Good Manufacturing Practices (GMP) and pharmacopeial standards such as USP, EP, or JP. Suppliers with comprehensive dossiers, stability data, and prior regulatory approval streamline the registration process.

Supplier Qualification and Validation

Manufacturers must implement rigorous qualification procedures, including onsite audits, batch record reviews, and quality audits. Preference is typically given to suppliers with Global Good Manufacturing Practice (GMP) certification, proven track records, and consistent supply stability.

Geographical Sourcing Strategy

While China, India, and Europe dominate API production, manufacturers should balance cost considerations against regulatory timelines and quality assurance. Asia-based suppliers often offer competitive pricing but necessitate thorough validation.

Supply Chain Continuity and Risk Management

Diversification of API sources mitigates risks related to geopolitical instability, supply chain disruptions, and regulatory changes. Establishing multiple qualified vendors for key APIs enhances resilience.

---

Regulatory Pathways and API Validation

API suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), stability data, and compliance certificates (e.g., GMP, ISO). Regulatory authorities such as the FDA, EMA, and PMDA scrutinize API quality during product registration.

In addition, batch-to-batch consistency and compliance with current Good Manufacturing Practices (cGMP) are paramount. These standards ensure APIs’ safety and efficacy for pediatric use, including Infuvite Pediatric.

---

Emerging Trends in API Sourcing

• Bioequivalence and Innovation: Increasing demand for biosynthetic or natural extract APIs with verified bioequivalence.
• Sustainability: Consumers and regulators emphasize sustainably sourced APIs, prompting suppliers to adopt environmentally friendly practices.
• Digital Supply Chains: Adoption of blockchain and digital tracking enhances transparency and traceability in API procurement.

---

Conclusion

Secure and compliant sourcing of APIs is foundational for manufacturing high-quality Infuvite Pediatric. Leading global suppliers such as BASF, DSM, Evonik, and Kyowa Hakko Kirin dominate the critical vitamin API space, while Chinese and Indian manufacturers provide cost-effective mineral APIs contingent upon thorough qualification. Ensuring supplier adherence to strict regulatory standards, maintaining supply chain resilience, and leveraging strategic diversification are key to sustaining the integrity of pediatric multivitamin formulations.

---

Key Takeaways

• API sourcing for Infuvite Pediatric involves multiple high-quality vitamin and mineral suppliers, with an emphasis on GMP compliance.
• Top suppliers include BASF, DSM, Evonik, Kyowa Hakko Kirin, and select Chinese and Indian manufacturers.
• Regulatory compliance with pharmacopeial standards is critical for pediatric formulations.
• Establishing a diversified supplier base mitigates supply chain and regulatory risks.
• Emerging trends focus on sustainability, bioequivalence, and digital transparency in API procurement.

---

FAQs

1. What are the primary factors to consider when sourcing APIs for pediatric multivitamin formulations?
Regulatory compliance, GMP certification, supplier reputation, bioequivalence, and supply stability are paramount to ensure safety, efficacy, and regulatory approval.

2. How do regulatory standards influence API selection for Infuvite Pediatric?
APIs must meet pharmacopeial standards (USP, EP, JP) and come with comprehensive documentation, including Certificates of Analysis and stability data, to facilitate regulatory approval processes.

3. Are Chinese and Indian API suppliers suitable for pediatric formulations?
Yes, many Chinese and Indian suppliers produce GMP-certified APIs suitable for pediatric products. However, thorough qualification, validation, and auditing are essential to mitigate risks.

4. How does supply chain diversification benefit API sourcing?
It reduces dependency on single sources, mitigates risks related to geopolitical issues, supply disruptions, and regulatory changes, ensuring consistent API supply.

5. What emerging trends are shaping API procurement for pediatric nutrients?
Sustainable sourcing, bioequivalence innovations, digital supply chain transparency, and stricter regulatory oversight are influencing how APIs are sourced and validated.

---

References

1. [1] Baxter, J. et al. (2022). "Global API Market Analysis," PharmTech.
2. [2] European Pharmacopoeia, European Directorate for the Quality of Medicines & HealthCare (EDQM), 2022.
3. [3] FDA Guidance for Industry: "Quality Systems Approach to Pharmaceutical Quality Assurance," FDA, 2019.
4. [4] Nutritional Outlook (2021). "Vitamin API Suppliers Responding to Pediatric Formulation Demands."
5. [5] World Health Organization. (2020). "Guidelines on pharmaceutical manufacturing standards."

---