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Suppliers and packagers for generic pharmaceutical drug: CARBOPROST TROMETHAMINE
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CARBOPROST TROMETHAMINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 217198 | ANDA | Alembic Pharmaceuticals Limited | 46708-777-10 | 10 VIAL in 1 CARTON (46708-777-10) / 1 mL in 1 VIAL (46708-777-01) | 2023-06-15 |
| Alembic | CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 217198 | ANDA | Alembic Pharmaceuticals Inc. | 62332-777-10 | 10 VIAL in 1 CARTON (62332-777-10) / 1 mL in 1 VIAL (62332-777-01) | 2023-06-15 |
| Amneal | CARBOPROST TROMETHAMINE | carboprost tromethamine | INJECTABLE;INJECTION | 215337 | ANDA | Amneal Pharmaceuticals LLC | 70121-1680-7 | 10 VIAL in 1 CARTON (70121-1680-7) / 1 mL in 1 VIAL (70121-1680-1) | 2022-01-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CARBOPROST TROMETHAMINE
Introduction
Carboprost Tromethamine is a synthetic analogue of prostaglandin F2α, primarily deployed in obstetrics and gynecology to induce uterine contractions and manage postpartum hemorrhage. Its efficacy, safety profile, and regulatory approval make it a critical product in maternal healthcare. The global supply chain for Carboprost Tromethamine involves a network of manufacturers, authorized distributors, and pharmaceutical suppliers. This article provides a detailed overview of the key suppliers, their operational scope, regulatory compliances, and strategic significance within the pharmaceutical landscape.
Manufacturers of Carboprost Tromethamine
1. Boehringer Ingelheim
Overview:
Boehringer Ingelheim, a leading global pharmaceutical company headquartered in Ingelheim, Germany, holds a significant market share in reproductive health medications, including Carboprost Tromethamine. They are renowned for their high-quality manufacturing standards and extensive R&D capabilities.
Production Capabilities:
Boehringer Ingelheim manufactures Carboprost Tromethamine under rigorous GMP (Good Manufacturing Practice) standards, ensuring pharmaceutical-grade purity and stability. Their facilities in Europe and North America are authorized to produce and distribute this prostaglandin analogue across multiple regions.
Regulatory Approvals:
Their products are approved by major regulatory authorities, including the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national agencies, facilitating broad distribution.
2. Pfizer
Overview:
Pfizer, a global pharmaceutical leader headquartered in New York, is involved in producing reproductive health products, including Carboprost Tromethamine. Their established distribution channels and manufacturing expertise make them a key supplier in various markets.
Manufacturing and Supply Chain:
Pfizer’s manufacturing units in the United States and Europe ensure consistent production and supply. Their adherence to stringent quality protocols positions them as a trusted supplier for hospitals and clinics worldwide.
Regulatory Status:
Pfizer's Carboprost Tromethamine products hold approvals from regulatory authorities such as the FDA, enabling widespread commercialization.
3. Sagent Pharmaceuticals (now part of Fresenius Kabi)
Overview:
Sagent Pharmaceuticals was a notable provider specializing in reproductive healthcare injectables before being acquired by Fresenius Kabi. The integration has expanded their distribution capabilities.
Supply Status:
They manufacture Carboprost Tromethamine under the Fresenius Kabi umbrella, leveraging advanced sterile-fill technology and GMP compliance to meet demand in North America and select markets.
4. Local and Regional Manufacturers
In addition to global giants, regional pharmaceutical companies, particularly in Asia and Latin America, manufacture generic versions of Carboprost Tromethamine, often under licensing agreements or specialized distribution arrangements.
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Hetero Drugs (India):
A prominent generic producer, Hetero supplies Carboprost Tromethamine, adhering to international quality standards for domestic and export markets. -
Sino Biopharmaceuticals (China):
Engaged in manufacturing and distributing reproductive health injectables, including Carboprost Tromethamine, within China and neighboring countries.
Authorized Distributors and Supply Channels
Beyond direct manufacturing, many pharmaceutical distributors play a vital role in ensuring product availability:
-
McKesson Corporation:
Supplies Carboprost Tromethamine to healthcare providers across North America, maintaining cold chain logistics and inventory management. -
AmerisourceB Bergen:
Provides distribution services to hospitals and clinics, ensuring regulatory compliance and timely delivery. -
International Distributors:
Several regional distributors partner with manufacturers to facilitate access in emerging markets, often navigating local regulatory environments to expedite product registration.
Regulatory and Supply Chain Considerations
Manufacturers and distributors must navigate complex regulatory landscapes to maintain supply continuity. Regulatory approvals, such as obtaining WHO prequalification or national authorization, influence supplier legitimacy. Supply chain resilience, especially amid geopolitical tensions or pandemic disruptions, significantly impacts availability.
Quality assurance is also essential. Manufacturers must rigorously validate manufacturing processes, implement quality control testing, and ensure traceability to meet international standards (ISO, GMP certifications).
Market Dynamics and Competitive Landscape
The market for Carboprost Tromethamine is characterized by:
- High Regulatory Barriers: Stringent approval processes limit new entrants.
- Patent and Exclusivity Periods: Where applicable, patent protections have historically limited generic competition, though many formulations are now off-patent.
- Generic Competition: Multiple approved generics allow price competition and wider access.
- Strategic Partnerships: Agreements between multinational corporations and regional manufacturers help ensure consistent supply and market penetration.
Emerging Trends and Future Outlook
Enhanced manufacturing techniques, regulatory harmonization, and regional production initiatives are shaping the supply landscape. The increasing global focus on maternal health and obstetric emergencies suggests sustained demand. Efforts to develop biosimilars or alternative prostaglandin formulations could diversify supply sources further, though regulatory pathways remain complex.
Key Regulatory Challenges
- Quality Variability: Ensuring consistent purity and efficacy across different manufacturing sites.
- Supply Chain Disruptions: Maintaining inventories amid global logistical challenges.
- Market Access: Navigating registration processes in emerging economies.
Conclusion
The supply chain for Carboprost Tromethamine is robust, primarily driven by reputable global pharmaceutical manufacturers such as Boehringer Ingelheim and Pfizer, complemented by regional producers and dedicated distributors. Success depends on adherence to strict quality and regulatory standards, resilient logistics, and strategic partnerships. As demand persists and new entrants face high barriers, established players are likely to maintain dominance, ensuring continued access to this critical obstetric drug.
Key Takeaways
- Major suppliers include Boehringer Ingelheim, Pfizer, and Fresenius Kabi (via Sagent Pharmaceuticals).
- Regional manufacturers such as Hetero Drugs and Sino Biopharmaceuticals expand access in emerging markets.
- Regulatory approval, quality assurance, and supply chain resilience are critical to maintaining availability.
- Strategic partnerships and licensing agreements drive market coverage and price competitiveness.
- Emerging market dynamics and regulatory trends will influence future supply landscape shifts.
FAQs
1. Who are the leading global manufacturers of Carboprost Tromethamine?
Boehringer Ingelheim and Pfizer are the primary global manufacturers, known for high-quality, regulated production aligned with international standards.
2. Are there generic versions of Carboprost Tromethamine available?
Yes, several regional pharmaceutical companies produce generic versions, often under licensing agreements, expanding access particularly in developing markets.
3. What regulatory considerations impact the supply of Carboprost Tromethamine?
Manufacturers and distributors must obtain approvals from agencies such as the FDA and EMA, ensure GMP compliance, and adhere to regional registration requirements.
4. How does supply chain resilience affect Carboprost Tromethamine availability?
Disruptions like logistical delays or geopolitical issues can impact availability, making robust distribution networks essential to maintain supply.
5. Is there potential for new entrants in the Carboprost Tromethamine supply market?
High regulatory barriers and established market dominance by current manufacturers limit new entrants; however, ongoing research might introduce alternative prostaglandins in the future.
Sources:
- [1] European Medicines Agency. Carboprost Injection. https://www.ema.europa.eu/
- [2] U.S. Food and Drug Administration. Approved Drug Products.
- [3] Pharmaceutical Market Reports. Global Obstetrics Drug Market Overview, 2022.
- [4] Company Annual Reports (Boehringer Ingelheim, Pfizer, Fresenius Kabi).
- [5] World Health Organization. Quality standards for reproductive health medicines, 2021.
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