Suppliers and packagers for cervidil

cervidil

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ferring Pharms Inc	CERVIDIL	dinoprostone	INSERT, EXTENDED RELEASE;VAGINAL	020411	NDA	Ferring Pharmaceuticals Inc.	55566-2800-1	1 POUCH in 1 CARTON (55566-2800-1) / 10 mg in 1 POUCH (55566-2800-0)	1995-03-30

Suppliers for the Pharmaceutical Drug: Cervidil

Last updated: August 4, 2025

Introduction

Cervidil (dinoprostone vaginal insert) is a specialized pharmaceutical used primarily for cervical ripening and induction of labor in obstetrics. As a prostaglandin E2 analog, Cervidil facilitates cervical softening and dilation, allowing for safer and more efficient labor induction. The global supply chain for Cervidil involves key manufacturers, authorized distributors, and regional suppliers ensuring wide availability across healthcare markets. For pharmaceutical companies, healthcare providers, and investors, understanding the landscape of Cervidil suppliers offers insight into market dynamics, regulatory considerations, and strategic procurement.

Manufacturers of Cervidil

1. Ferring Pharmaceuticals

Ferring remains the sole manufacturer of Cervidil worldwide. Since its initial approval, Ferring has maintained exclusive rights to produce, distribute, and market Cervidil, positioning it as a leader in the cervical ripening segment.

• Product Portfolio: Ferring’s Cervidil offers a biodegradable, controlled-release vaginal insert containing dinoprostone, designed for outpatient use with a removable delivery system.
• Global Reach: Ferring’s extensive global distribution network ensures availability across North America, Europe, Asia, and other regions, often via regional subsidiaries and licensed distributors.

Regulatory Status:
Cervidil holds regulatory approvals from agencies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other health authorities worldwide, typically through registration processes managed directly by Ferring or licensed partners.

2. Licensing and Distribution Rights

While Ferring is the exclusive manufacturer, regional licensing agreements sometimes involve local pharmaceutical companies under licensing arrangements, particularly in emerging markets to facilitate regional distribution and local regulatory compliance.

Key Regional Partners:

• In some countries, local entities hold distribution rights for Cervidil, enabling faster market penetration and adaptation to regional regulatory requirements.

Regional Suppliers and Distributors

North America

• Primary Supplier: Ferring Pharmaceuticals is the principal supplier directly responsible for the distribution of Cervidil in the United States, Canada, and Mexico.
• Distribution Networks: Major hospital networks, pharmacy chains, and regional distributors source Cervidil directly from Ferring or licensed distributors.

Europe

• European Markets: Ferring holds direct marketing authorization, supported by regional distribution partners across European Union (EU) member states.
• Regulatory Compliance: The drug’s distribution adheres to the centralized and national authorization processes of the EMA and individual member states.

Asia-Pacific

• Market Dynamics: Ferring often partners with local pharmaceutical distributors and agents to navigate regulatory hurdles and ensure timely supply.
• Emerging Markets: Countries like India, China, and Southeast Asia often rely on licensed regional distributors, which may include subsidiaries or authorized importers.

Emerging Markets and Developing Countries

• Often served by regional distribution agreements, generic licensing (if applicable), or imports directly from Ferring’s regional offices.
• Suppliers Note: In some markets where patent rights or exclusivity are challenged, generic versions with similar formulations may be available, supplied by local or regional manufacturers.

Market Access and Supply Chain Considerations

Regulatory Approvals

Ferring’s exclusive rights to manufacture Cervidil mean that all suppliers and distributors in authorized markets depend on Ferring’s regulatory filings. Regional regulatory hurdles influence supply chain agility and product availability.

Supply Chain Risks

• Manufacturing Disruptions: Given Ferring’s sole manufacturing position, any production disruptions, regulatory delays, or quality issues can significantly impact Cervidil availability.
• Regulatory Changes: Evolving safety or efficacy evidence can lead to re-approvals or restrictions affecting supply continuity.

Pricing and Reimbursement

Pricing strategies depend on regional market dynamics, reimbursement policies, and negotiations with health authorities. Suppliers often work within these frameworks to facilitate continuous supply.

Emerging Alternatives and Market Competition

Despite Ferring’s exclusivity, the market has seen the emergence of alternatives, including other prostaglandin formulations such as misoprostol, which are often supplied by generic manufacturers.

• Generic Alternatives: In some regions, licensed generic versions of dinoprostone are marketed, creating potential competition or supply flexibility for healthcare providers.
• Impact on Cervidil Suppliers: Market competition can influence procurement strategies, procurement prices, and supply chain resilience.

Conclusion

Cervidil remains a drug with a concentrated supply chain, primarily managed by Ferring Pharmaceuticals. The exclusive manufacturing rights position Ferring as the central supplier, with regional partners facilitating distribution. Critical factors impacting supply include regulatory approvals, manufacturing capacity, regional licensing agreements, and market competition. Stakeholders must monitor these components to ensure consistent access and optimal procurement strategies.

Key Takeaways

• Ferring Pharmaceuticals is the sole manufacturer of Cervidil globally, ensuring brand control but also concentrated supply risk.
• Regional licensing agreements enable supply chain flexibility, particularly in emerging markets.
• Supply disruptions can significantly impact availability due to Ferring’s exclusive production rights.
• Market competition via generic alternatives influences pricing and procurement strategies.
• Staying informed on regulatory changes and regional distribution partnerships is vital for stakeholders managing Cervidil supply.

FAQs

Q1: Is Cervidil available from multiple manufacturers?
A: No. Cervidil is exclusively manufactured by Ferring Pharmaceuticals. However, generic versions of dinoprostone, the active ingredient, are produced by other companies.

Q2: How does regional licensing affect Cervidil supply?
A: Licensing agreements enable local distributors to supply Cervidil, facilitating regional market access and regulatory compliance, especially where Ferring’s direct presence is limited.

Q3: What risks exist in the supply chain of Cervidil?
A: Key risks include manufacturing delays at Ferring, regulatory changes, and geopolitical factors affecting logistics and distribution.

Q4: Are there generic alternatives to Cervidil?
A: Yes. Several generics containing dinoprostone are available in some regions, often supplied by local or independent manufacturers.

Q5: How might market competition impact Cervidil suppliers?
A: The presence of effective generic competitors can pressure prices, influence procurement strategies, and potentially impact the available supply volume of Cervidil.

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References

1. Ferring Pharmaceuticals. Cervidil Product Information.
2. U.S. Food and Drug Administration (FDA). Cervidil (dinoprostone) approval documentation.
3. European Medicines Agency (EMA). Summary of Product Characteristics for Cervidil.
4. Asian regional pharmaceutical distribution channels review.