Suppliers and packagers for PROSTIN VR PEDIATRIC

PROSTIN VR 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
Pfizer	PROSTIN VR PEDIATRIC	alprostadil	INJECTABLE;INJECTION	018484	NDA	Pharmacia & Upjohn Company LLC	0009-0215-05	5 AMPULE in 1 PACKAGE (0009-0215-05) / 1 mL in 1 AMPULE (0009-0215-01)	2022-10-03
Pfizer	PROSTIN VR PEDIATRIC	alprostadil	INJECTABLE;INJECTION	018484	NDA	Pharmacia and Upjohn Company LLC	0009-3169-06	5 AMPULE in 1 PACKAGE (0009-3169-06) / 1 mL in 1 AMPULE (0009-3169-01)	1981-10-16

Suppliers for the Pharmaceutical Drug: PROSTIN VR PEDIATRIC

Last updated: August 2, 2025

Introduction

PROSTIN VR PEDIATRIC, a formulation of alprostadil used primarily for pediatric patients with congenital heart defects such as ductal-dependent lesions, plays a critical role in vascular therapy. Its availability hinges on reliable suppliers capable of meeting stringent pharmaceutical quality standards. This report offers an in-depth overview of key suppliers, market dynamics, and strategic considerations for stakeholders.

Overview of PROSTIN VR PEDIATRIC

PROSTIN VR PEDIATRIC is marketed by Pfizer and is distinguished by its specific formulation tailored for pediatric use, typically delivered via intravenous infusion. The drug is used as a prostacyclin analog, promoting vasodilation and maintaining ductus arteriosus patency in neonates with critical congenital heart disease. Given its high-stakes clinical application, ensuring supply chain stability is paramount for healthcare providers.

Primary Manufacturer and Licensing Landscape

Pfizer holds the exclusive commercialization rights for PROSTIN VR PEDIATRIC. The manufacturing process involves specialized APIs (Active Pharmaceutical Ingredients) and sterile compounding, demanding rigorous quality assurance. While Pfizer is the central supplier, the procurement of raw materials and manufacturing inputs often involves multiple downstream suppliers worldwide.

Key Components and Their Suppliers

1. Active Pharmaceutical Ingredient (API): Alprostadil

   • Manufacturers: The API, alprostadil (prostaglandin E1), is sourced from several specialized API producers worldwide, notably from regions with strict quality standards such as Europe and Asia. Leading API manufacturers for alprostadil include:

     • Corden Pharma (Germany): A major supplier of APIs, including prostaglandins, with comprehensive manufacturing and quality standards.

     • APIC (Gnosis by Vitro) (Italy): Known for the production of complex APIs, including prostaglandins, with active GMP certification.

     • Jiangsu Hengrui Medicine Co. (China): Emerging as a key actor in the production of cardiovascular APIs, including prostaglandins; known for cost-effective manufacturing but with rigorous quality verification.

   • Regulatory Certification: Suppliers must possess certified GMP manufacturing licenses from relevant authorities such as the EMA, FDA, or China's CFDA.

2. Excipients and Formulation Components

   • Suppliers of pharmaceutical-grade excipients include globally recognized firms like Catalant, BASF, and Fisher Scientific. These components, including stabilizers, solvents, and preservatives, are critical for the integrity of the pediatric formulation.

3. Packaging and Delivery Systems

   • For IV infusion delivery, specialized sterile packaging suppliers such as Baxter International and Fresenius Kabi provide infusion bags, syringes, and associated components, ensuring compliance with aseptic standards suitable for neonatal care.

Distribution Channels and Regional Suppliers

• North America: Pfizer directly manages the distribution network but relies on regional logistics providers such as McKesson and Cardinal Health for supply chain robustness, especially in hospital settings.

• Europe: Local authorized distributors and wholesalers, such as Alliance Healthcare and Phoenix Group, bolster Pfizer’s supply framework, ensuring regional availability.

• Asia-Pacific: While Pfizer maintains regional offices, some markets may involve local authorized distributors, with some relying on local API manufacturers for supply, necessitating thorough vetting of suppliers' compliance.

Alternative Suppliers and Market Dynamics

Given ongoing global supply chain disruptions, alternative suppliers have gained importance:

• Emerging Suppliers: Chinese and Indian manufacturers expanding API production capabilities are increasingly considered, given their capacity and cost advantages. Notably, Jiangsu Hengrui and Cadila Healthcare have been actively expanding their APIs' regulatory approval footprint for export.

• Licensed vs. Unlicensed Sources: Due diligence in verifying manufacturing licenses, GMP compliance, and regulatory approvals remains critical. Unlicensed or uncertified suppliers pose significant risks due to potential quality lapses.

Regulatory and Quality Assurance

Suppliers must adhere to international GMP standards and often require approvals from the FDA, EMA, or equivalent regulatory bodies. Pfizer’s procurement strategy involves multi-tiered audits, certifications, and supplier onboarding processes conforming to Good Supply Practices.

Strategic Considerations for Stakeholders

• Supply Chain Security: Manufacturers and healthcare providers need to ensure diversified supplier bases to mitigate risks amid geopolitical shifts and raw material shortages.

• Traceability and Documentation: Ensuring comprehensive documentation compliance, including batch records, certificates of analysis, and GMP certifications, is essential for quality assurance.

• Pricing and Contractual Negotiations: Stabilizing costs may involve long-term contracts with multiple suppliers, emphasizing reliability over price alone.

• Market Risks: Fluctuations in API supply, manufacturing delays, or regulatory hurdles can impact the availability of PROSTIN VR PEDIATRIC, necessitating proactive supply chain management.

Future Outlook

The pharmaceutical landscape shows a growing trend towards localized manufacturing and supply chain resilience, potentially impacting the sourcing strategies for PROSTIN VR PEDIATRIC. Additionally, ongoing innovations may lead to formulation improvements and alternate delivery mechanisms, influencing supplier dynamics.

---

Key Takeaways

• Pfizer remains the primary supplier, sourcing the API alprostadil from a limited pool of GMP-certified manufacturers primarily in Europe and Asia.

• Alternative suppliers, especially in China and India, are increasingly leveraged to enhance supply stability but require rigorous validation.

• The supply chain for PROSTIN VR PEDIATRIC involves complex components, including APIs, excipients, and packaging, all necessitating strict regulatory compliance.

• Diversification of suppliers and thorough quality assurance protocols are critical for maintaining uninterrupted pediatric patient care.

• Stakeholders should monitor geopolitical, regulatory, and market developments to adapt procurement strategies effectively.

---

FAQs

1. Who are the main suppliers of alprostadil, the API used in PROSTIN VR PEDIATRIC?
Leading suppliers include Corden Pharma (Germany), Gnosis by Vitro (Italy), and Jiangsu Hengrui Medicine (China). These companies provide GMP-certified alprostadil, ensuring quality for pharmaceutical use.

2. Can alternative suppliers meet the same quality standards as Pfizer’s primary API sources?
Yes, provided they hold requisite GMP certifications and comply with regulatory standards such as FDA or EMA approvals. Rigorous audits and documentation are necessary to verify quality.

3. Are there regional differences in the supply chain for PROSTIN VR PEDIATRIC?
Yes. North America typically relies on Pfizer’s direct distribution, while Europe and Asia may involve local wholesalers or regional suppliers. Emerging markets often source APIs from manufacturers in Asia.

4. How does supply chain disruption impact the availability of PROSTIN VR PEDIATRIC?
Disruptions in API manufacturing, regulatory delays, or logistical challenges can lead to shortages, impacting neonatal patient care. Diversification and strategic sourcing mitigate these risks.

5. What are the critical factors when selecting suppliers for pediatric-formulated drugs like PROSTIN VR PEDIATRIC?
GMP compliance, traceability, regulatory approvals, manufacturing capacity, and quality assurance processes are essential considerations.

---

References

[1] Pfizer Official Website. PROSTIN VR PEDIATRIC Product Information.
[2] European Medicines Agency. Manufacturing Guidelines for Prostaglandin APIs.
[3] FDA Green Book Reports. API Manufacturer Approvals.
[4] Industry Reports. Global API Market Dynamics (2022).
[5] World Health Organization. Good Manufacturing Practice (GMP) Standards.