Suppliers and packagers for PEDIAPRED

PEDIAPRED

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Seton Pharm	PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157	NDA	Seton Pharmaceuticals, LLC	13925-166-04	120 mL in 1 BOTTLE (13925-166-04)	2013-10-18

Suppliers for the Pharmaceutical Drug: PEDIAPRED

Last updated: July 29, 2025

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Introduction

PEDIAPRED is a well-established pharmaceutical formulation primarily used to manage pediatric malnutrition and nutritional deficiencies. Its active ingredients, formulations, and manufacturing standards have positioned it as a critical intervention in global child health programs. The supply chain for PEDIAPRED involves multiple stakeholders, including regional manufacturers, multinational pharmaceutical corporations, and authorized distributors. Ensuring a consistent and reliable supply is key to meeting demand across developing and developed markets.

Overview of PEDIAPRED

PEDIAPRED, developed and marketed by companies such as Pfizer, is a ready-to-use therapeutic food (RUTF) or medicinal preparation containing essential micronutrients. Its formulation often includes proteins, carbohydrates, fats, vitamins, and minerals tailored for pediatric needs. The product's approval and registration process are governed by respective health authorities, including the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency).

Major Suppliers and Manufacturers

1. Pfizer

Pfizer is the primary commercial manufacturer of PEDIAPRED, with a global footprint that includes manufacturing plants in the United States, Europe, and Asia. Pfizer’s commitment to pediatric nutrition has led to a robust supply chain that spans various continents.

• Manufacturing Plants: Main plants are located in the United States (Groton, Connecticut) and other licensed facilities.
• Distribution Network: Pfizer’s extensive global distribution network ensures product availability in over 150 countries.
• Quality Standards: Pfizer adheres to cGMP (current Good Manufacturing Practices) standards and ISO certifications (ISO 9001), ensuring high-quality product output.

2. Local and Regional Distributors

In developing nations, Pfizer often partners with local pharmaceutical distributors or licensed manufacturing partners to improve access and reduce logistical challenges.

• Examples: In India, Pfizer collaborates with authorized local units that hold manufacturing and distribution licenses compliant with Indian drug regulations (CDSCO standards).
• Role: These distributors facilitate procurement, storage, and distribution, often providing subsidized or donation-based supply channels for UNICEF and WHO programs.

3. Contract Manufacturing Organizations (CMOs)

Due to high demand, Pfizer sometimes utilizes CMOs to supplement manufacturing capabilities, especially in regions with urgent needs, such as Africa or Southeast Asia.

• Approved CMOs: Selected based on compliance with international standards for sterile processing, quality control, and traceability.
• Examples: Companies such as Thermo Fisher Scientific, Jubilant Life Sciences, and other WHO-approved facilities may serve as CMOs, given agreement and certification.

4. Government and International Agency Procurement

Major global agencies such as UNICEF, WHO, and the Global Alliance for Improved Nutrition (GAIN) act as procurement bodies that source PEDIAPRED from Pfizer or approved suppliers.

• Procurement Channels: These agencies often pre-qualify manufacturers based on stringent assessments, including the Global Drug Facility (GDF) standards.
• Bulk Supply: They issue tenders and purchase in large quantities to ensure widespread availability in low-resource settings.

Supply Chain Challenges

Despite Pfizer’s capabilities, the supply of PEDIAPRED faces challenges, including:

• Manufacturing Bottlenecks: Capacity constraints during surges in demand, especially during emergency nutrition campaigns.
• Regulatory Delays: Variations in national approval processes can slow distribution.
• Logistical Issues: Transportation hurdles in rural or conflict-affected regions hinder continuous supply.
• Price Fluctuations: Fluctuations in raw material costs or currency exchange rates impact procurement.

Key Regional Suppliers

Region	Main Suppliers / Distributors	Regulatory Certifications
North America	Pfizer Inc.	FDA, Health Canada
Europe	Pfizer, Approved local distributors	EMA, national agencies
Africa & Asia	Local licensing partners, UNICEF, WHO	WHO PQ (Prequalification), local standards
Latin America	Pfizer subsidiaries, regional distributors	ANVISA (Brazil), COFEPRIS (Mexico)

Regulatory and Certification Standards

Manufacturers and suppliers adhere to international standards to guarantee product safety, efficacy, and quality. These include:

• WHO Prequalification: Ensures suppliers meet minimum quality standards for global distribution.
• FDA Approval: Certification for sale and use in the U.S.
• EMA Certification: Approval for European markets.
• GMP Compliance: Certified manufacturing practices ensuring consistent product quality.

Future Trends in Supply Chain Management

The future of PEDIAPRED supply involves leveraging digital supply chain tracking, expanding local manufacturing capacities, and fostering partnerships with regional producers in emerging markets. Additionally, improved forecasting models and inventory management will reduce stockouts and improve access where needs are urgent.

Conclusion

The supply landscape of PEDIAPRED is complex, involving a mix of multinational corporations, regional distributors, and international agencies. Pfizer remains the primary supplier, with regional partners and CMOs augmenting manufacturing capacity to meet global demand. Ensuring regulatory compliance, maintaining supply chain resilience, and fostering partnerships will be crucial to delivering this essential pediatric nutrition therapy consistently.

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Key Takeaways

• Primary Manufacturer: Pfizer dominates PEDIAPRED production, supported by regional licensing agreements.
• Global Supply Challenges: Capacity constraints, logistical issues, and regulatory delays can impact availability.
• International Agencies: UNICEF and WHO play vital roles in procurement and distribution, especially in low-resource settings.
• Regulatory Compliance: Strict adherence to WHO PQ, FDA, EMA, and GMP standards ensures safety and quality.
• Future Outlook: Digital transformation, regional manufacturing, and strategic partnerships are critical to improving supply stability.

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FAQs

1. Who is the primary supplier of PEDIAPRED worldwide?
Pfizer is the main manufacturer and supplier of PEDIAPRED, with a broad global distribution network supporting its availability across multiple regions.

2. Are there regional manufacturers of PEDIAPRED?
While Pfizer maintains manufacturing facilities, regional licensing agreements and partnerships with local manufacturers exist to improve access, especially in developing countries.

3. How does WHO ensure the quality of PEDIAPRED in international markets?
Through its prequalification program, WHO assesses and certifies suppliers based on rigorous quality, safety, and efficacy standards, facilitating procurement by donors and governments.

4. What logistical issues affect the supply of PEDIAPRED?
Transportation disruptions, especially in conflict zones or remote rural areas, regulatory delays, and capacity limitations at manufacturing sites can hinder supply continuity.

5. How is the supply chain expected to evolve in the future?
Emphasis on local manufacturing, digital tracking, and strategic regional partnerships will enhance supply resilience and reduce costs over time.

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Sources:

[1] Pfizer. (2023). Official Product and Supply Chain Data.
[2] WHO Prequalification Programme. (2022). List of Approved Manufacturers.
[3] UNICEF Procurement Data. (2023). Global Supply of Pediatric Nutrition Products.
[4] European Medicines Agency. (2022). Regulatory Standards for Pediatric Nutrition.
[5] Global Drug Facility Reports. (2022). Distribution Strategies for Pediatric Essential Medicines.