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

Pediapred Supply Chain Analysis

Last updated: February 19, 2026

This report details the primary suppliers for Pediapred, a corticosteroid drug formulated for pediatric use. It examines the active pharmaceutical ingredient (API) sourcing and key excipient providers critical to Pediapred's manufacturing.

What is Pediapred's Active Pharmaceutical Ingredient (API)?

Pediapred's API is prednisolone [1]. Prednisolone is a synthetic corticosteroid with potent anti-inflammatory and immunosuppressive properties. It is used to treat a wide range of conditions, including allergic reactions, asthma, autoimmune diseases, and certain types of cancer. The chemical formula for prednisolone is C21H26O5 [2].

Who Manufactures Prednisolone API for Pediapred?

The manufacturing of prednisolone API is a complex chemical synthesis process. Key global suppliers of prednisolone API include:

• Hubei Banghai Biotechnology Co., Ltd. (China): This company lists prednisolone as a product in its pharmaceutical intermediate portfolio.
• Nantong Changbang Biopharmaceutical Co., Ltd. (China): Another Chinese entity identified as a producer of prednisolone API.
• Hengrui Medicine Co., Ltd. (China): A significant pharmaceutical manufacturer in China that produces various APIs, including corticosteroids.
• Hetero Drugs Ltd. (India): A major Indian pharmaceutical company known for its extensive API manufacturing capabilities, including steroid compounds.
• Lupin Ltd. (India): An Indian multinational pharmaceutical company with a broad API production base.
• Sun Pharmaceutical Industries Ltd. (India): India's largest pharmaceutical company, with substantial API manufacturing operations for a range of therapeutic categories.
• Teva Pharmaceutical Industries Ltd. (Israel): A global leader in generic pharmaceuticals, Teva also produces APIs for its formulations and for sale to other manufacturers.
• AbbVie Inc. (USA): While primarily known for its finished drug products, AbbVie (and its predecessor Abbott Laboratories) has historically been involved in steroid API manufacturing.

The specific supplier for Pediapred's prednisolone API is not publicly disclosed by the brand manufacturer due to proprietary supply chain agreements. However, these companies represent the primary global sources for this critical API.

Prednisolone API: Key Characteristics and Manufacturing Standards

The synthesis of prednisolone API adheres to stringent pharmaceutical quality standards. These include:

• Good Manufacturing Practices (GMP): Manufacturers must comply with international GMP guidelines (e.g., FDA, EMA) to ensure API quality, purity, and consistency.
• Pharmacopoeial Standards: Prednisolone API must meet the specifications outlined in major pharmacopoeias such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP). This includes requirements for identity, assay, impurities, and physical characteristics [3].
• Impurity Profiling: Rigorous testing is performed to identify and quantify process-related impurities and degradation products, ensuring the API is safe for human consumption.

The cost and availability of prednisolone API can be influenced by global supply and demand, regulatory changes, and raw material costs.

What Excipients are Crucial for Pediapred Formulations?

Pediapred is typically formulated as an oral solution or suspension, requiring a specific set of excipients to ensure stability, palatability, and proper delivery of the API. Key excipients commonly found in pediatric prednisolone oral solutions include:

Solvents and Co-solvents

• Purified Water: The primary solvent for most oral liquid formulations. It meets stringent purity standards (e.g., USP Purified Water).
• Glycerin (Glycerol): A humectant and co-solvent, it helps to dissolve the API and improve the mouthfeel of the solution.

Suspending Agents and Thickeners

• Xanthan Gum: A polysaccharide used as a suspending agent to keep the insoluble or poorly soluble API particles uniformly dispersed in the liquid vehicle, preventing sedimentation.
• Microcrystalline Cellulose and Carboxymethylcellulose Sodium: Often used in combination as suspending agents and binders, forming a gel matrix to stabilize suspensions.

Sweeteners

• Sucrose: A common disaccharide used as a sweetener.
• Sorbitol: A sugar alcohol that provides sweetness and acts as a humectant.
• Artificial Sweeteners (e.g., Sucralose, Saccharin): Used to enhance palatability, especially in formulations designed for children.

Flavoring Agents

• Various Fruit Flavors (e.g., Cherry, Grape, Orange): Added to mask the bitter taste of the API and improve patient compliance. These are typically proprietary blends.

Preservatives

• Sodium Benzoate: A widely used antimicrobial preservative to prevent microbial growth in aqueous formulations.
• Potassium Sorbate: Another common preservative, often used in conjunction with sodium benzoate.
• Methylparaben and Propylparaben: Preservatives effective against a broad spectrum of microorganisms.

Buffering Agents

• Citric Acid: Used to adjust and maintain the pH of the formulation.
• Sodium Citrate: Works with citric acid to create a buffer system, crucial for API stability and solubility.

Other Potential Excipients

• Disodium Edetate (EDTA): A chelating agent that can help sequester metal ions, improving product stability.
• Antioxidants (e.g., Ascorbic Acid): Used to prevent degradation of the API or other formulation components due to oxidation.

Who are the Suppliers of These Key Excipients?

The excipient market is diverse, with numerous global suppliers. For Pediapred formulations, the following types of companies are primary sources:

Suppliers of Water and Solvents

• Bulk Water Suppliers: Pharmaceutical-grade purified water is typically produced on-site at the drug manufacturing facility according to USP standards.
• Glycerin Suppliers:
  • Croda International Plc (UK): A global specialty chemical company producing oleochemicals, including high-purity glycerin.
  • KLK Oleo (Malaysia): A major producer of oleochemicals.
  • BASF SE (Germany): A diversified chemical company with a strong presence in oleochemicals.

Suppliers of Suspending Agents and Thickeners

• Xanthan Gum Suppliers:
  • CP Kelco (USA): A leading producer of hydrocolloids, including xanthan gum.
  • ADM (Archer Daniels Midland) (USA): A global agricultural processing and food ingredient provider.
  • Jungbunzlauer (Switzerland): A producer of biodegradable ingredients for food, pharmaceutical, and cosmetic industries.
• Microcrystalline Cellulose (MCC) and Carboxymethylcellulose Sodium (CMC-Na) Suppliers:
  • DuPont de Nemours, Inc. (USA): Offers a range of MCC and CMC products under brands like Avicel.
  • Ashland Global Holdings Inc. (USA): A supplier of specialty chemicals, including cellulosic derivatives.

Suppliers of Sweeteners

• Sucrose and Sorbitol Suppliers: Numerous global food and chemical ingredient suppliers. Examples include:
  • Cargill, Incorporated (USA)
  • Ingredion Incorporated (USA)
  • Roquette Frères (France)
• Artificial Sweetener Suppliers: Specialized chemical manufacturers.

Suppliers of Flavoring Agents

• Flavor and Fragrance Companies: These are highly specialized, often with proprietary formulations. Examples include:
  • Givaudan SA (Switzerland)
  • Firmenich International SA (Switzerland)
  • International Flavors & Fragrances Inc. (IFF) (USA) The specific flavor used in Pediapred would be a proprietary blend developed by or for the brand manufacturer.

Suppliers of Preservatives

• BASF SE (Germany): A major supplier of parabens.
• Sintetica S.p.A. (Italy): Produces various pharmaceutical ingredients, including preservatives.
• Various Fine Chemical Manufacturers: Many global chemical companies supply sodium benzoate and potassium sorbate.

Suppliers of Buffering Agents and Other Excipients

• Citric Acid and Sodium Citrate Suppliers:
  • Tate & Lyle PLC (UK)
  • Jungbunzlauer (Switzerland)
  • ADM (USA)
• Disodium Edetate (EDTA) and Antioxidant Suppliers: Specialty chemical manufacturers.

The selection of excipient suppliers is based on quality, regulatory compliance, supply chain reliability, and cost-effectiveness. Pharmaceutical companies conduct extensive audits of their excipient suppliers to ensure adherence to GMP and pharmacopoeial standards.

Supply Chain Risks and Mitigation for Pediapred

The supply chain for a pharmaceutical product like Pediapred is subject to various risks.

API Sourcing Risks

• Geopolitical Instability: A significant portion of API manufacturing is concentrated in specific regions (e.g., China, India). Geopolitical tensions, trade disputes, or natural disasters in these regions can disrupt supply.
• Regulatory Changes: Evolving environmental regulations or changes in manufacturing oversight in API-producing countries can impact production capacity and costs.
• Quality Control Failures: Batch failures or recalls due to API quality issues can lead to significant supply shortages and reputational damage.
• Single-Source Dependency: Reliance on a single API manufacturer for a critical component creates a high-risk scenario.

Mitigation Strategies:

• Dual Sourcing: Establishing relationships with at least two qualified API manufacturers in different geographical locations.
• Supplier Audits and Qualification: Rigorous and continuous auditing of API suppliers to ensure ongoing compliance with quality and regulatory standards.
• Inventory Management: Maintaining adequate safety stock levels for critical APIs.
• Long-Term Contracts: Securing supply through long-term agreements with price and volume protections.

Excipient Sourcing Risks

• Market Volatility: Fluctuations in the cost of raw materials for excipients (e.g., agricultural commodities for natural gums and sweeteners).
• Disruption to Specialty Chemical Production: Issues affecting manufacturers of highly purified or specialized excipients.
• Quality Consistency: Ensuring consistent quality across different batches and suppliers of excipients.

Mitigation Strategies:

• Diversified Supplier Base: Working with multiple approved suppliers for key excipients.
• Supplier Qualification Programs: Implementing stringent quality control and auditing for all excipient suppliers.
• Ingredient Specification Management: Clearly defining all critical quality attributes for each excipient.
• Alternative Excipient Evaluation: Proactively researching and qualifying alternative excipients in case of primary supplier issues.

Manufacturing and Distribution Risks

• Production Facility Downtime: Unforeseen events at the finished product manufacturing site (e.g., equipment failure, contamination).
• Logistics Disruptions: Issues in the transportation and cold chain (if applicable) of finished products to distribution centers and pharmacies.
• Regulatory Compliance: Maintaining ongoing compliance with all relevant manufacturing and distribution regulations.

Mitigation Strategies:

• Redundant Manufacturing Capabilities: Having backup manufacturing sites or contract manufacturing organizations (CMOs).
• Robust Quality Management Systems: Implementing comprehensive QMS to monitor and control all aspects of manufacturing.
• Supply Chain Visibility: Utilizing technology to track inventory and product movement throughout the supply chain.
• Business Continuity Planning: Developing and regularly testing plans to address various disruption scenarios.

By actively managing these risks through diversification, rigorous qualification, and robust planning, pharmaceutical companies can enhance the resilience of the Pediapred supply chain.

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Key Takeaways

• Pediapred's API is prednisolone, a widely manufactured corticosteroid.
• Key API suppliers are primarily located in China and India, with global players also involved.
• Excipients required for Pediapred formulations include solvents, suspending agents, sweeteners, flavors, preservatives, and buffers.
• Excipient suppliers range from large chemical conglomerates to specialized flavor houses.
• Supply chain resilience for Pediapred relies on dual sourcing for APIs and excipients, rigorous supplier qualification, and proactive risk mitigation strategies against geopolitical, quality, and logistical disruptions.

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Frequently Asked Questions

1. Are there any single-source critical suppliers for Pediapred's API? While the specific manufacturer is proprietary, the global supply of prednisolone API is generally diverse. However, reliance on any single geographical region for a significant portion of this supply poses a systemic risk.
2. What is the primary quality standard for Pediapred's API? Prednisolone API must comply with pharmacopoeial standards such as those defined in the United States Pharmacopeia (USP) or European Pharmacopoeia (EP), and be manufactured under Good Manufacturing Practices (GMP).
3. How are the flavors in Pediapred developed? Flavors are proprietary blends developed by specialized flavor and fragrance companies, often in collaboration with the pharmaceutical brand owner, to enhance palatability for pediatric patients and mask the API's bitterness.
4. What measures are in place to ensure the stability of Pediapred's liquid formulation? Stability is ensured through the careful selection of excipients, including buffering agents to control pH, preservatives to prevent microbial degradation, and suspending agents to maintain API uniformity, all manufactured to pharmaceutical grade and stored under specified conditions.
5. Can a disruption in one excipient's supply impact Pediapred's availability? Yes, a significant disruption affecting a critical excipient, such as a key suspending agent or preservative, can impact Pediapred's production and availability if alternative suppliers or excipients are not readily qualified and available.

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Citations

[1] U.S. Food & Drug Administration. (n.d.). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ [2] National Center for Biotechnology Information. (n.d.). PubChem Compound Summary for CID 5753, Prednisolone. PubChem. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Prednisolone [3] United States Pharmacopeial Convention. (n.d.). Pharmacopeial Forum. Retrieved from https://www.uspnf.com/