Share This Page
Suppliers and packagers for generic pharmaceutical drug: dinoprostone
✉ Email this page to a colleague
dinoprostone
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 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Dinoprostone
Introduction
Dinoprostone, chemically known as prostaglandin E2 (PGE2), is a naturally occurring prostaglandin widely used in obstetrics and gynecology. It functions primarily as a cervical ripening agent and as a medical termination agent of pregnancy. Given its critical role in managing labor and pregnancy-related conditions, a global network of suppliers ensures its availability across various markets. This article provides an in-depth analysis of dinoprostone suppliers, their manufacturing capabilities, regulatory compliance, and market dynamics.
Overview of Dinoprostone
Dinoprostone is marketed under various formulations, including gels, vaginal inserts, and suppositories, offering clinicians diverse options tailored to specific clinical needs. The drug’s efficacy and safety profile necessitate stringent manufacturing standards, often aligning with Good Manufacturing Practice (GMP) guidelines. Its synthesis involves complex organic processes, typically reliant on biologically derived or chemically synthesized prostaglandin E2.
Major Suppliers of Dinoprostone
1. Ferring Pharmaceuticals
Ferring Pharmaceuticals stands as a global leader in reproductive medicine and gynecology, supplying dinoprostone under the brand name Cervidil. The company holds several key patents and has a comprehensive manufacturing facility capable of scaling production to meet global demand. Ferring emphasizes high-quality standards, extensive clinical data, and regulatory approvals across North America, Europe, and Asia.
2. Pfizer Inc.
Pfizer manufactures dinoprostone formulations, primarily focusing on labor induction and pregnancy management. The company’s global footprint enables rapid distribution across multiple jurisdictions. Pfizer’s manufacturing processes adhere strictly to GMP standards, ensuring consistent drug quality and safety.
3. Novartis AG
Novartis produces prostaglandin E2 derivatives, including dinoprostone, catering notably to European and Asian markets. Their products are distinguished by advanced delivery systems, such as controlled-release vaginal inserts, which improve patient compliance and clinical outcomes.
4. Boehringer Ingelheim
Though primarily known for respiratory and cardiovascular medications, Boehringer Ingelheim also supplies prostaglandin analogs, including dinoprostone, especially in regional markets. They leverage robust R&D capabilities to develop improved formulations and delivery mechanisms.
5. Local and Regional Manufacturers
Apart from large pharmaceutical companies, several regional producers supply generic versions of dinoprostone, particularly in emerging markets. These manufacturers often focus on cost-effective production, while ensuring adherence to local regulatory standards.
Manufacturing and Supply Chain Considerations
Quality Assurance and Regulatory Compliance:
Manufacturers must comply with international GMP standards. Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA, Japan) rigorously evaluate manufacturing processes.
Supply Chain Dynamics:
The raw materials for dinoprostone synthesis are sensitive to quality and sourcing. Many suppliers have secured reliable supply chains through vertical integration, ensuring steady availability. However, disruptions in raw material supply or regulatory challenges can impact global distribution.
Formulation and Delivery Innovations:
Leading manufacturers are investing in innovative delivery systems—such as biodegradable vaginal inserts and controlled-release gels—that enhance therapeutic efficacy and patient compliance.
Regulatory Landscape and Market Impact
Manufacturers must obtain regulatory approvals for each formulation and market. Variations in regulatory requirements can influence manufacturing practices and supply capability. Patents and exclusivity rights in certain countries also shape market competition, affecting prices and accessibility.
The rising global demand for cervical ripening agents and obstetric care products bolsters the market for dinoprostone. Industry players are also focusing on establishing robust distribution channels to meet acute pandemic-related disruptions and prevent shortages.
Market Trends and Future Outlook
The dinoprostone market is expected to grow steadily, driven by increasing obstetric care needs and innovations in drug delivery methods. Biotech advancements may lead to bioengineered prostaglandin analogs, potentially expanding supply sources and reducing reliance on traditional synthetic routes.
Furthermore, strategic partnerships and licensing agreements facilitate broader market reach, especially in emerging economies. However, regulatory hurdles and quality standards remain essential considerations for market entrants.
Key Challenges for Suppliers
- Ensuring consistent raw material quality amid global supply fluctuations.
- Navigating heterogeneous regulatory environments across countries.
- Developing formulations that satisfy both efficacy and patient comfort.
- Managing intellectual property rights, especially in countries where patents have expired.
Key Takeaways
- Major global suppliers of dinoprostone include Ferring Pharmaceuticals, Pfizer, Novartis, and Boehringer Ingelheim, complemented by regional manufacturers.
- Supply chain integrity, regulatory compliance, and formulation innovation are critical to maintaining market supply.
- The evolving landscape favors increased use of controlled-release delivery systems, improving clinical outcomes.
- Rising demand in obstetric care drives ongoing investments in manufacturing capacity and product development.
- Strategic collaborations are instrumental in expanding access, particularly in emerging markets.
FAQs
1. What are the primary formulations of dinoprostone available in the market?
Dinoprostone is available as vaginal gels, intra cervical inserts (e.g., Cervidil), and suppositories. The choice depends on clinical needs, patient comfort, and practitioner preference.
2. Which regulatory agencies approve dinoprostone products worldwide?
Major regulatory approvals come from the FDA (USA), EMA (Europe), and PMDA (Japan). Each agency evaluates formulations' safety, efficacy, and manufacturing standards.
3. Are generic versions of dinoprostone widely available?
Yes. Several regional manufacturers produce generic dinoprostone, particularly in emerging markets. However, product quality depends on adherence to local GMP and regulatory standards.
4. What are the main challenges faced by dinoprostone suppliers?
Challenges include raw material supply disruptions, navigating diverse regulatory landscapes, ensuring consistent formulation quality, and maintaining competitive pricing.
5. How might future developments impact dinoprostone supply?
Advances in bioengineering prostaglandin analogs and controlled-release delivery systems could diversify supply sources, improve efficacy, and alter market dynamics, possibly reducing reliance on traditional syntheses.
References
- K. S. Kothari, et al., "Prostaglandins in Obstetrics," Obstetrics & Gynecology, vol. 124, no. 4, 2014, pp. 769–779.
- Ferring Pharmaceuticals. "Cervidil Product Overview," 2022.
- Pfizer Inc. Official Website, "Dinoprostone formulations," 2022.
- European Medicines Agency. "Dinoprostone-based Medicines," EudraLex, 2023.
- Market analysis reports on obstetric drugs, 2022.
Note: The above references are representative; access to current peer-reviewed literature and regulatory documents is recommended for detailed insights.
More… ↓
