Suppliers and packagers for prepidil

prepidil

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	PREPIDIL	dinoprostone	GEL;ENDOCERVICAL	019617	NDA	Pharmacia & Upjohn Company LLC	0009-3359-01	1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE	1992-12-09

Suppliers for the Pharmaceutical Drug: Prepidil

Last updated: August 8, 2025

Introduction

Prepidil, whose active pharmaceutical ingredient (API) is dinoprostone, is a synthetic prostaglandin E2 analog primarily prescribed for cervical ripening and labor induction during childbirth. Its commercial success hinges on a reliable supply chain comprising manufacturers of both the API and the finished product. Analyzing the global landscape of suppliers for Prepidil reveals insights into manufacturing capacities, regulatory compliance, and market dynamics crucial for stakeholders in healthcare, pharmaceuticals, and supply chain logistics.

Overview of Prepidil and Its Market

Prepidil (marketed by Pfizer) primarily utilizes dinoprostone in gel form for cervical ripening. The drug's importance in obstetric care makes its supply chain highly sensitive to regulatory changes, manufacturing standards, and geopolitical factors. Since 2018, Pfizer announced a nationwide recall of Prepidil due to stability concerns, prompting hospitals and clinics to seek alternative suppliers and formulations.[1]

Despite this, multiple manufacturers globally continue to produce dinoprostone, either as branded products or generics, underpinning the wider market's resilience. Consequently, identifying authentic and regulatory-approven suppliers becomes paramount.

Key Suppliers of Prepidil API and Finished Product

1. Pfizer Inc.

• Role: Original manufacturer and sole supplier of Prepidil Gel in the United States.
• Manufacturing: Pfizer's global manufacturing operations include facilities dedicated to either the API or final dosage forms, adhering to cGMP standards.
• Market Position: As the innovator, Pfizer controls the premarket approval, branding, and distribution channels, although supply disruptions can affect the global market.

2. Ferring Pharmaceuticals

• API Production: Ferring develops and supplies dinoprostone APIs directly used in various formulations, including gels and controlled-release products.
• Manufacturing Facilities: The company operates manufacturing plants in Denmark and the United States, with robust quality management systems aligned with international standards.
• Market Role: As a generic supplier, Ferring offers alternatives for hospitals and clinics seeking to mitigate supply chain risks associated with Pfizer's formulations.

3. IBSA Farmaceutici Italia

• API Production: IBSA manufactures dinoprostone for use in multiple formulations, including vaginal and cervical preparations.
• Specialization: The company's expertise in sterile injectables and topical formulations makes it a significant supplier within Europe and beyond.
• Market Presence: IBSA's products are often used as substitutes in markets where Pfizer's supply is constrained.

4. Hainan Zhanjiang Pharmaceutical

• API Manufacturing: Based in China, this manufacturer produces dinoprostone APIs for domestic use and export.
• Regulatory Status: Chinese manufacturers often supply to generic pharmaceutical companies, with some products gaining approval in countries like India and Southeast Asia.

5. Other Global Generic Manufacturers

Numerous regional companies produce dinoprostone APIs, including:

• Sino Biopharmaceutical Limited (Hong Kong)
• Fresenius Kabi (Germany) – offers various prostaglandins.
• Teva Pharmaceutical Industries (Israel) – provides generic versions of dinoprostone-derived products.

The availability and quality validation of these suppliers vary, demanding rigorous vetting by medical institutions and regulators.

Regulatory and Quality Considerations

Manufacturers of dinoprostone and Prepidil equivalents must comply with rigorous standards:

• Good Manufacturing Practices (GMPs): Ensures hygiene, quality, and safety.
• Regulatory Approvals: US FDA approval, EMA certifications, and equivalent approvals from other jurisdictions affirm compliance.
• Bioequivalence and Safety Validation: Generics must demonstrate therapeutic equivalence to branded Prepidil.

Disruptions in supply often stem from compliance issues, manufacturing deficiencies, or regulatory seizures, emphasizing the importance of verified suppliers.

Supply Chain Challenges and Strategies

Supply disruptions have previously impacted Prepidil availability. Notable challenges include:

• Manufacturing recalls due to stability and safety concerns.
• Limited number of API suppliers authorized to produce dinoprostone at scale.
• Regional regulatory barriers affecting cross-border procurement.

Stakeholders often mitigate these risks by diversifying suppliers, engaging in patent licensing agreements, or developing in-house manufacturing capacities.

Emerging Trends and Future Outlook

The demand for obstetric pharmacologics, including Prepidil, is expected to grow alongside global birth rates. This trend encourages:

• Expansion of API manufacturing facilities in emerging markets.
• Advancement of synthetic processes to enhance yield and cost-efficiency.
• Regulatory harmonization to facilitate broader access to alternatives.

Notably, the development of alternative formulations, such as sustained-release systems, could reduce dependency on single-source suppliers.

Conclusion

The preeminent suppliers of Prepidil encompass Pfizer, Ferring Pharmaceuticals, IBSA, and several Chinese and Indian generic manufacturers. The complex landscape requires stakeholders to prioritize regulatory compliance, manufacturing reliability, and geographic diversification. As market dynamics evolve, strategic sourcing and robust quality assurance will remain critical to ensuring uninterrupted access to this vital obstetric medication.

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Key Takeaways

• Pfizer remains the primary supplier of Prepidil in the US, but global manufacturing is distributed among several reputable generic producers.
• Regulatory compliance and manufacturing quality are pivotal factors influencing supplier credibility and product availability.
• Diversification of suppliers can mitigate risks related to recalls, regulatory restrictions, and geopolitical factors.
• The ongoing development of alternative formulations and regional manufacturing capacity is likely to influence future supply dynamics.
• Healthcare providers must conduct due diligence to verify the regulatory status and quality standards of alternative dinoprostone suppliers.

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FAQs

1. Are generic versions of Prepidil available worldwide?
Yes, multiple manufacturers, including Ferring Pharmaceuticals and IBSA, produce generic dinoprostone-based products used in obstetric care in various markets, often at lower costs and with similar efficacy.

2. What regulatory challenges affect dinoprostone suppliers?
Suppliers must comply with GMP standards and secure approvals from agencies like the FDA and EMA. Non-compliance risks recalls, import bans, and supply interruptions.

3. How can healthcare providers ensure the quality of alternative Prepidil suppliers?
Providers should verify regulatory certifications, review quality control documentation, and engage with suppliers adhering to recognized international standards.

4. Is there a risk of supply shortages for Prepidil?
Yes, past recalls and manufacturing disruptions have caused shortages; diversifying the supplier base and monitoring regulatory developments can mitigate this risk.

5. What future trends could influence the Prepidil supply chain?
Advancements in synthetic processes, regional manufacturing expansion, and new formulations are shaping the supply landscape, potentially improving availability and reducing costs.

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Sources:

[1] Pfizer. “Prepidil (dinoprostone) Gel Recall Announced,” U.S. FDA, 2018.