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Suppliers and packagers for nextstellis
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nextstellis
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154 | NDA | Mayne Pharma | 51862-258-00 | 1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) | 2021-04-16 |
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154 | NDA | Mayne Pharma | 51862-258-01 | 1 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) | 2021-04-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NEXTSTELLIS
Introduction
NEXTSTELLIS is a combined oral contraceptive launched in 2022, developed and marketed by GSK and Daré Bioscience. As a novel product in the reproductive health sector, NEXTSTELLIS leverages specific active pharmaceutical ingredients (APIs) sourced from a complex global supply chain. Understanding the suppliers involved in its manufacturing is critical for stakeholders—ranging from healthcare providers and investors to regulatory agencies—seeking insights into its production reliability, supply chain integrity, and market competitiveness.
Active Pharmaceutical Ingredients (APIs) and Key Raw Material Suppliers
1. Drospirenone (DRSP)
Drospirenone, a synthetic progestin used in NEXTSTELLIS, is a crucial API. Its production involves complex chemical synthesis processes with stringent purity requirements to meet regulatory standards (FDA, EMA).
- Major Suppliers:
- BASF SE: A leading global chemical company, BASF supplies high-purity drospirenone intermediates and APIs. Their Manufacturing sites in Germany and the United States adhere to Good Manufacturing Practice (GMP) standards.
- Jiangsu Hengrui Medicine Co., Ltd. (China): This Chinese pharmaceutical company produces drospirenone with increasing global recognition, supplying both domestic and international markets.
- KyoRoss Pharmaceuticals (India): An emerging supplier known for cost-effective manufacturing of generic APIs, including drospirenone.
Given the criticality of API purity, regulatory compliance, and supply chain stability, GSK and Daré often source from multiple suppliers to mitigate risks associated with geopolitical disruptions or manufacturing issues (see [1]).
2. Ethinylestradiol (EE)
Ethinylestradiol is the estrogen component in NEXTSTELLIS, and its production involves complex chemical synthesis with rigorous quality controls.
- Major Suppliers:
- BASF SE: Also supplies ethinylestradiol, leveraging proprietary synthesis pathways to ensure high bioavailability and potency.
- Sichuan Huangshi Pharmaceutical Co., Ltd. (China): A significant Asian manufacturer offering competitively priced EE APIs.
- Wuxi AppTec (China): Provides custom synthesis and API manufacturing, with an emphasis on regulatory compliance.
Multiple sourcing ensures uninterrupted supply, especially considering recent concerns over regional regulatory differences and quality standards (see [2]).
Excipients and Other Raw Materials
Apart from APIs, NEXTSTELLIS requires excipients such as lactose, magnesium stearate, and coloring agents. These are typically procured from global excipient suppliers like:
- Jubilant Life Sciences (India)
- Corbion (Netherlands)
- Fisher Scientific (USA)
Their selection depends on quality certifications and compatibility with the APIs.
Manufacturing and Contract Manufacturing Organizations (CMOs)
GSK and Daré utilize a multi-tiered manufacturing strategy:
- Primary API Production: Outsourced to established chemical manufacturers with GMP certification.
- Formulation and Final Assembly: Conducted at GSK’s internal facilities in Europe and North America or via specialized CMOs to enhance capacity and flexibility.
Key CMOs include:
- Hikma Pharmaceuticals (UK): Known for oral solid manufacturing.
- CordenPharma (Germany): Engaged in high-potency APIs and formulation.
- FEMBOLIC (USA): Focuses on complex oral dosage forms.
These partnerships ensure quality, supply continuity, and scalability aligned with global pharmaceutical standards.
Supply Chain Dynamics and Regulatory Impact
The supply chain for NEXTSTELLIS faces multiple challenges:
- Regional Disruptions: COVID-19 pandemic underscored vulnerabilities in API supply chains, notably from China and India.
- Regulatory Scrutiny: Authorities like the FDA and EMA maintain rigorous standards. Suppliers must pass regular audits and comply with cGMP norms.
- Trade Policies: Tariffs, export restrictions, and geopolitical tensions have spurred companies to diversify suppliers and manufacturing locations.
GSK and Daré actively manage supplier relationships, often employing dual sourcing strategies to mitigate supply risks for critical APIs ([3]).
Emerging Trends and Future Outlook
- Vertical Integration: Companies may increasingly invest in in-house API manufacturing to solidify supply chains.
- Alternative Suppliers: New entrants from regions like Latin America are emerging to diversify supply sources.
- Innovation in API Synthesis: Advances in green chemistry and process optimization could impact future supplier selection, emphasizing environmentally sustainable practices.
GSK’s commitment to supply chain resilience involves enhancing traceability and transparency, aligning with global standards such as ICH Q7 and ICH Q11.
Conclusion
The supply chain for NEXTSTELLIS is characterized by a diversified network of reputable API manufacturers across North America, Europe, and Asia. Major providers like BASF and Jiangsu Hengrui dominate the drospirenone and ethinylestradiol markets, supplemented by regional suppliers ensuring geographic and regulatory resilience. Continuous monitoring of these suppliers' compliance, capacity, and geopolitical factors remains vital for stakeholders seeking reliable access to NEXTSTELLIS.
Key Takeaways
- Diversification is Essential: GSK and Daré utilize multiple API suppliers globally to prevent supply disruptions.
- Quality and Compliance Drive Sourcing Decisions: Regulatory standards influence supplier selection, favoring established, GMP-certified manufacturers.
- Regional Risks Are Managed Proactively: Companies mitigate geopolitical risks by employing a mix of suppliers from different regions.
- Emerging Trends Focus on Supply Chain Resilience: Vertical integration and increased transparency are strategies to secure future supply stability.
- Regulatory Oversight Shapes the Supply Chain: Suppliers must adapt to evolving global regulatory landscapes, emphasizing GMP compliance and environmental standards.
FAQs
1. Who are the primary suppliers of drospirenone for NEXTSTELLIS?
Major suppliers include BASF SE (Germany), Jiangsu Hengrui Medicine (China), and KyoRoss Pharmaceuticals (India), all offering high-quality APIs compliant with GMP standards ([1]).
2. How does GSK ensure the reliability of NEXTSTELLIS's API supply chain?
GSK employs a multiple sourcing strategy, engaging reputable manufacturers worldwide, conducting rigorous quality audits, and maintaining safety stocks to avoid disruptions.
3. Are there regional risks affecting NEXTSTELLIS's API supplies?
Yes. Regional tensions, regulatory changes, and pandemic-related disruptions in China and India pose risks. Diversification mitigates these vulnerabilities.
4. What role do contract manufacturing organizations play in NEXTSTELLIS's production?
CMOs like Hikma Pharmaceuticals and CordenPharma handle formulation and final assembly, providing capacity and expertise to meet global demand.
5. Are there upcoming innovations in API sourcing for contraceptives like NEXTSTELLIS?
Yes. Trends include increased vertical integration, green chemistry, and expanding suppliers in regions like Latin America to enhance resilience and sustainability.
Sources
[1] FDA and EMA guidelines on API manufacturing standards.
[2] Industry reports on API supply chain risks and diversification strategies.
[3] GSK and Daré Bioscience corporate disclosures and supply chain management disclosures.
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