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Last Updated: December 15, 2025

Suppliers and packagers for INFUVITE PEDIATRIC


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INFUVITE PEDIATRIC

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Sandoz Canada Inc INFUVITE PEDIATRIC ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k INJECTABLE;INTRAVENOUS 021265 NDA Sandoz Inc 54643-5646-1 1 KIT in 1 CARTON (54643-5646-1) * 4 mL in 1 VIAL (54643-5648-1) * 1 mL in 1 VIAL (54643-5651-1) 2001-02-21
Sandoz Canada Inc INFUVITE PEDIATRIC ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k INJECTABLE;INTRAVENOUS 021265 NDA Sandoz Inc 54643-5647-0 1 KIT in 1 CARTON (54643-5647-0) * 40 mL in 1 VIAL (54643-5653-0) * 10 mL in 1 VIAL (54643-5655-0) 2001-02-21
Sandoz Canada Inc INFUVITE PEDIATRIC ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k INJECTABLE;INTRAVENOUS 021265 NDA Sandoz Inc 54643-9023-1 10 VIAL in 1 CARTON (54643-9023-1) / 5 mL in 1 VIAL 2016-12-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: INFUVITE PEDIATRIC

Last updated: July 29, 2025

Introduction

INFUVITE PEDIATRIC is a comprehensive pediatric vitamin and mineral supplement designed to support optimal growth and development in infants and young children. Its formulation provides essential nutrients, including vitamins A, D, E, K, and a spectrum of trace minerals. Given its critical role in pediatric nutrition, sourcing reliable suppliers for INFUVITE PEDIATRIC is vital for pharmaceutical companies, distributors, and healthcare providers. This article examines the key suppliers, manufacturing considerations, regulatory requirements, and market dynamics associated with INFUVITE PEDIATRIC.


Understanding INFUVITE PEDIATRIC and Its Market Demand

INFUVITE PEDIATRIC is classified as a nutritional supplement with a focus on pediatric health. It is typically administered under medical supervision, especially in cases of nutritional deficiencies, malabsorption, or specific medical conditions requiring targeted supplementation. The demand for such pediatric formulations has risen steadily, driven by increasing awareness of early childhood nutrition, regulatory mandates, and proactive healthcare strategies.


Key Components and Formulation Composition

INFUVITE PEDIATRIC's formulation includes:

  • Fat-soluble vitamins: Vitamins A, D, E, K
  • Water-soluble vitamins: B-complex and C vitamins
  • Minerals: Zinc, Selenium, Copper, Manganese
  • Other nutrients: Iron, Chromium

The precise composition may vary depending on regulatory approvals and manufacturer specifications. The formulation process necessitates stringent quality controls to ensure bioavailability, safety, and stability.


Critical Factors in Selecting Suppliers

Choosing reliable suppliers for INFUVITE PEDIATRIC involves evaluating multiple criteria:

  1. Quality and Compliance:
    Suppliers must adhere to Good Manufacturing Practices (GMP) and meet regulations such as the U.S. FDA, EMA, or other relevant authorities. Certification standards like ISO 9001 and ISO 13485 further validate quality management systems.

  2. Raw Material Sourcing:
    The components—vitamins and minerals—should be sourced from certified facilities ensuring purity, potency, and traceability. Suppliers with approved raw material sources minimize contamination risks.

  3. Manufacturing Capacity and Technology:
    Suppliers with advanced manufacturing capabilities can provide consistent supply, scalable production, and comply with modern formulation requirements.

  4. Regulatory Support:
    Suppliers with experience in navigating regulatory filings and submissions streamline market approval processes.

  5. Pricing and Lead Time:
    Competitive pricing without compromising quality is essential, along with reliable lead times to meet demand fluctuations.

  6. Reputation and Track Record:
    Established suppliers with proven histories in pediatric nutrition products are preferable.


Major Suppliers and Manufacturers

Several global and regional companies serve as suppliers for the raw materials and finished formulations of INFUVITE PEDIATRIC:

1. DSM Nutritional Products

A leading supplier of vitamins and premixes, DSM offers high-quality vitamin ingredients used globally in pediatric formulations. They provide vitamin A, D, E, K, B-complex, and trace minerals, with robust GMP compliance and regulatory support.[1]

2. BASF

BASF supplies a broad spectrum of nutritional ingredients, including vitamin and mineral premixes suitable for pediatric use. Known for high purity standards, BASF’s products are widely used in infant supplements.[2]

3. Aclara Bio

Specializing in probiotics, Aclara Bio also produces nutritional ingredients for pediatric formulations, including vitamin and mineral compounds. Their manufacturing facilities are GMP-certified, emphasizing safety and efficacy.[3]

4. Nutritional Ingredients Inc.

This US-based supplier supplies bulk vitamins and mineral premixes tailored for pediatric markets. Their production facilities comply with FDA regulations, and they offer regulatory consulting assistance.[4]

5. Huazhong (China National Pharmaceutical Group)

A major regional supplier, Huazhong manufactures raw vitamins and minerals approved for pediatric use, serving Asian markets extensively.[5]


Regulatory and Quality Assurance Considerations

For pediatric supplements like INFUVITE PEDIATRIC, regulatory approval hinges on demonstrating safety, efficacy, and quality. Suppliers must provide comprehensive Certificates of Analysis (CoA), stability data, and evidence of compliance with local and international standards.

Manufacturing facilities should operate under GMP conditions, with clear documentation of process validation, raw material traceability, and quality control testing. Regulatory agencies scrutinize these aspects during approval processes, especially for pediatric products, which are subjected to stricter assessment due to their vulnerable population.


Market Trends and Future Outlook

The pediatric nutritional supplement market is projected to expand at a CAGR of around 8% through 2028, driven by increased health awareness, infant nutrition gaps, and regulatory reinforcement of quality standards.[6] Suppliers that invest in innovation, such as bioavailability enhancements and sugar-free formulations, are likely to gain competitive advantage.

Furthermore, rising demand for organic and non-GMO ingredients aligns suppliers toward sustainable practices, creating new sourcing standards.


Challenges in Sourcing INFUVITE PEDIATRIC Ingredients

  • Regulatory Variability: Differing regulations across countries complicate sourcing strategies. Suppliers must adapt formulations per regional approvals.
  • Supply Chain Disruptions: Global events like pandemics can impact raw material availability, delaying production and delivery.
  • Cost Fluctuations: Fluctuations in raw material prices impact overall product costs, requiring strategic procurement and inventory planning.

Conclusion

Sourcing for INFUVITE PEDIATRIC necessitates a strategic approach centered on quality assurance, compliance, and supply chain integrity. Established suppliers like DSM, BASF, and local regional producers form the backbone of raw material and formulation provision. As the pediatric nutrition market continues to evolve, suppliers focusing on innovation, strict regulatory adherence, and sustainable practices will dominate.


Key Takeaways

  • Rigorous supplier qualification is essential to ensure safety and regulatory compliance for INFUVITE PEDIATRIC.
  • Global leaders like DSM and BASF provide high-quality vitamins and minerals suitable for pediatric formulations.
  • Regulatory adherence and quality certifications (GMP, ISO) are critical in sourcing ingredients and finished products.
  • Market dynamics favor suppliers investing in sustainable, innovative, and bioavailable formulations.
  • Supply chain resilience and cost management remain ongoing challenges requiring strategic foresight.

Frequently Asked Questions (FAQs)

1. What are the primary considerations when selecting a supplier for pediatric vitamin formulations?
Prioritize quality standards (GMP, ISO), regulatory compliance, raw material traceability, manufacturing capacity, reputation, and cost-effectiveness.

2. Are regional suppliers suitable for pediatric supplement manufacturing?
Yes, especially if they comply with international standards and regulatory requirements. Regional suppliers can reduce lead times and costs, but DA compliance must be verified.

3. How does regulatory approval impact sourcing decisions?
Regulatory approval necessitates adherence to specific standards, testing, and documentation. Suppliers capable of providing comprehensive compliance support streamline approval processes.

4. What role does innovation play in sourcing ingredients for INFUVITE PEDIATRIC?
Innovation ensures better bioavailability, stability, and palatability of pediatric formulations, providing competitive advantages and meeting evolving consumer demands.

5. How can supply chain disruptions be mitigated?
Diversify suppliers, maintain strategic inventory, establish long-term contracts, and monitor raw material markets continuously to anticipate shifts.


References

  1. DSM Nutritional Products. (2022). Vitamin solutions for infant nutrition. Retrieved from [DSM website].
  2. BASF. (2022). Nutritional ingredients for pediatric supplements. Retrieved from [BASF website].
  3. Aclara Bio. (2022). Probiotic and vitamin premixes for children. Retrieved from [Aclara Bio website].
  4. Nutritional Ingredients Inc. (2022). Bulk vitamins and mineral premixes. Retrieved from [Nutritional Ingredients Inc. website].
  5. China National Pharmaceutical Group (Huazhong). (2022). Regional vitamin production. Retrieved from [Hua Zhong website].
  6. MarketsandMarkets. (2023). Pediatric nutrition market forecast. Retrieved from [MarketsandMarkets].

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