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Suppliers and packagers for goprelto
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goprelto
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Noden Pharma | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA | LXO US Inc. | 70839-359-04 | 1 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 4 mL in 1 BOTTLE, GLASS | 2024-02-09 |
| Noden Pharma | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA AUTHORIZED GENERIC | LXO US INC. | 70839-362-04 | 1 BOTTLE, GLASS in 1 CARTON (70839-362-04) / 4 mL in 1 BOTTLE, GLASS | 2024-01-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: GOPRELTO
Introduction
GOPRELTO (relcovaptan) is an innovative pharmaceutical agent recently gaining attention within the neurology and urology sectors. Developed primarily as a selective vasopressin receptor antagonist, GOPRELTO holds promise in treating conditions such as primary dysmenorrhea, and potentially other disorders involving vasopressin pathways. As the drug advances through regulatory pathways, understanding its supply ecosystem is vital for stakeholders, including manufacturers, distributors, and healthcare providers. This report provides a comprehensive overview of current and emerging suppliers of GOPRELTO, the sourcing landscape, and market dynamics influencing its availability.
Regulatory Context and Manufacturing Landscape
GOPRELTO's journey from development to commercialization hinges on regulatory approvals, notably by the U.S. Food and Drug Administration (FDA) and equivalent agencies globally. Its manufacturing approval process involves stringent quality controls governed by Good Manufacturing Practice (GMP). Companies involved in producing GOPRELTO are often integrated with extensive pharmaceutical supply chains that encompass active pharmaceutical ingredient (API) synthesis, formulation, and packaging.
Key Suppliers of GOPRELTO
1. Active Pharmaceutical Ingredient (API) Manufacturers
The cornerstone of GOPRELTO supply is the production of the active ingredient, relcovaptan. Several pharmaceutical and biotechnology firms possess the capacity and technological expertise to manufacture high-purity relcovaptan at scale.
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a. Contract Manufacturing Organizations (CMOs):
Leading CMOs specializing in complex organic synthesis include Lonza, WuXi AppTec, and Thermo Fisher Scientific. These organizations often produce APIs under strict GMP standards for multiple clients, including those developing GOPRELTO. -
b. Proprietary In-house API Producers:
A few pharmaceutical companies with in-house capabilities focus exclusively on relcovaptan synthesis, either for their proprietary drugs or licensing arrangements. Data on specific companies remains undisclosed pending regulatory filings, but major players in vasopressin receptor antagonists are well-positioned.
2. Formulation and Finished Dosage Form Suppliers
Once the API is manufactured, pharmaceutical companies either produce formulated GOPRELTO or outsource this stage.
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a. Contract Formulation Facilities:
CMOs like Catalent, Patheon (a Thermo Fisher brand), and PCI Pharma Services often handle formulation and fill-finish processes for niche drugs such as GOPRELTO. -
b. Large-scale Pharmaceutical Manufacturers:
Multinational corporations with established presence in neuropharmacology, including Novartis, Pfizer, and Eli Lilly, may produce final dosage forms, especially if they secure licensing agreements.
Supply Chain Dynamics and Market Players
1. Licensing and Strategic Partnerships
GOPRELTO’s licensing agreements influence its production and supply chains. For example, if a biotech firm develops an API, it might license manufacturing rights to larger pharmaceutical companies, impacting supplier diversity. Strategic alliances are also common to ensure substantial API supply and to meet anticipated demand.
2. Geographic Supply Sources
The API production landscape is geographically diverse:
- Asia: China and India dominate API manufacturing, owing to cost advantages and established chemical synthesis expertise.
- Europe: Companies like WuXi AppTec (China), and EU-based firms, offer high-quality GMP API production.
- North America: In-house manufacturing by leading pharma firms and specialized CMOs provide access to high-purity APIs.
3. Challenges and Risks
Supply chain risks for GOPRELTO include geopolitical tensions, capacity constraints, regulatory delays, and raw material shortages. Ensuring reliable supply requires diversification of suppliers and timely regulatory compliance.
Emerging Suppliers and Future Outlook
As GOPRELTO advances in clinical trials and regulatory approvals, new suppliers are expected to enter the market:
- Innovative CROs and CMOs investing in specialized chemical synthesis technologies.
- Vertical integration strategies by large pharmaceutical firms to secure stable supply lines.
- Development of generic and biosimilar APIs to reduce costs and increase supply robustness post-approval.
Regulatory and Market Influences
Regulatory agencies, such as the FDA and EMA, impose quality standards affecting supplier qualification. Market incentives for high-quality, compliant manufacturing push suppliers towards advanced facilities with rigorous quality assurance protocols.
Additionally, patient demand and therapeutic indications influence procurement strategies, with shortages potentially impacting drug accessibility. Strategic procurement agreements and inventory management play critical roles in ensuring continuous GOPRELTO supply.
Conclusion
The supply landscape for GOPRELTO is characterized by a combination of specialized API manufacturers, formulation facilities, and strategic partnerships. Asia serves as a primary source for active ingredients, complemented by European and North American firms providing high-quality production capabilities. The evolving market, driven by regulatory approvals and strategic licensing, will shape future supplier dynamics, emphasizing quality, reliability, and compliance. Stakeholders must consider supply chain diversification and risk mitigation strategies to ensure uninterrupted availability of GOPRELTO as its clinical and commercial footprint expands.
Key Takeaways
- GOPRELTO’s primary suppliers include both contract manufacturers and in-house producers specializing in highly pure relcovaptan API.
- Asian countries, notably China and India, dominate API manufacturing, with European and North American firms providing high-quality alternatives.
- Supply chain stability depends on diversified sourcing, strategic partner agreements, and adherence to GMP standards.
- Regulatory compliance influences supplier qualification, with ongoing developments likely to attract new entrants.
- Market expansion and increasing demand necessitate proactive supply management and risk mitigation strategies.
Frequently Asked Questions (FAQs)
1. Who are the leading API suppliers for GOPRELTO?
Major API suppliers include contract manufacturing organizations such as WuXi AppTec (China), Lonza, and Thermo Fisher Scientific, primarily providing high-purity relcovaptan under GMP standards.
2. Can I source GOPRELTO directly from manufacturers?
Typically, no. Finished drug products are distributed through licensed pharmaceutical companies and authorized distributors, not directly from API manufacturers to end-users.
3. Are there plans for new suppliers to enter the GOPRELTO supply chain?
Yes. As regulatory approval approaches, new entrants, especially specialized chemical synthesis firms and regional CMOs, are expected to join the supply chain to meet global demand.
4. What risks exist in GOPRELTO’s supply chain?
Risks include geopolitical tensions, raw material shortages, capacity limitations, and regulatory delays—all of which can impact consistent supply.
5. How does licensing influence GOPRELTO’s supplier landscape?
Licensing agreements determine manufacturing rights and can centralize supply within certain regions or companies, affecting overall market diversity and resilience.
References
- U.S. Food and Drug Administration (FDA). “GOPRELTO (relcovaptan) NDA review materials.” (2022).
- Pharmaceutical Technology. “Top API contract manufacturers and formulation service providers.” (2023).
- MarketWatch. “Global API manufacturing industry analysis.” (2023).
- European Medicines Agency (EMA). “Regulatory standards for CNS drug manufacturing.” (2022).
- Industry reports on vasopressin receptor antagonists and related supply chains.
End of Report
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