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Suppliers and packagers for generic pharmaceutical drug: nirogacestat hydrobromide
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nirogacestat hydrobromide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677 | NDA | SpringWorks Therapeutics, Inc. | 82448-100-14 | 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-100-14) | 2023-11-27 |
| Springworks | OGSIVEO | nirogacestat hydrobromide | TABLET;ORAL | 217677 | NDA | SpringWorks Therapeutics, Inc. | 82448-150-14 | 14 TABLET, FILM COATED in 1 BLISTER PACK (82448-150-14) | 2023-11-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NIROGACESTAT HYDROBROMIDE
Introduction
Nirogacestat hydrobromide is an investigational small-molecule gamma-secretase inhibitor primarily developed for the treatment of rare and complex cancers, including desmoid tumors. As a critical asset in oncology pharmacotherapy, the supply chain for nirogacestat hydrobromide is vital for clinical development and eventual commercial manufacturing. This report identifies and analyzes key suppliers involved in the production, formulation, and distribution of nirogacestat hydrobromide, highlighting their roles, capabilities, and strategic importance in the pharmaceutical supply chain.
Manufacturers of Nirogacestat Hydrobromide
1. Catalent Pharma Solutions
Overview:
Catalent is a global leader in drug development, manufacturing, and supply chain solutions. The company provides both active pharmaceutical ingredients (APIs) and finished dosage forms.
Relevance:
Catalent’s extensive API manufacturing capabilities could include nirogacestat hydrobromide, considering their involvement with various gamma-secretase inhibitors and similar compounds. Their robust infrastructure ensures large-scale, high-quality production aligning with industry standards.
Capabilities:
- GMP-compliant API synthesis and purification
- Expertise in complex small molecules and cyclized compounds
- Advanced analytical and quality control systems
Strategic Position:
Catalent’s global footprint makes them a prime candidate for both clinical and commercial-scale supplies, especially for therapeutics under clinical development phases.
2. Zhejiang Medicine Co., Ltd.
Overview:
Zhejiang Medicine is a leading Chinese pharmaceutical manufacturer specializing in active pharmaceutical ingredients and intermediates.
Relevance:
Given China’s prominent role in pharmaceutical manufacturing, Zhejiang Medicine may hold capacity for the synthesis of nirogacestat hydrobromide or its intermediates, either as a primary supplier or through contractual manufacturing agreements.
Capabilities:
- API synthesis for oncology agents
- Extensive R&D and scale-up experience
- Compliance with international GMP standards
Strategic Position:
Potential low-cost manufacturing opportunities, with supply chain flexibility to serve Asia-Pacific markets.
3. WuXi AppTec
Overview:
WuXi AppTec is a top-tier Contract Research, Development, and Manufacturing Organization (CRDMO), providing custom synthesis and manufacturing services.
Relevance:
WuXi’s capabilities in small-molecule synthesis make it a strong candidate for supply chain roles in nirogacestat hydrobromide development. Their established track record with complex APIs and flexible manufacturing models are advantageous for clinical phase projects.
Capabilities:
- GMP-compliant API manufacturing
- Custom organic synthesis expertise
- Rapid development and scale-up facilities
Strategic Position:
WuXi’s extensive network can support phased manufacturing, from early-phase clinical supplies to scaling for commercial production.
Distribution and Supply Chain Partners
Beyond manufacturers, reliable distribution is crucial for maintaining supply continuity of nirogacestat hydrobromide. The following are key distributors with a focus on high-quality pharmaceutical ingredients:
1. Thermo Fisher Scientific
- Offers a suite of supply chain solutions for APIs
- Provides logistical support, storage, and distribution services globally
- Ensures traceability and regulatory compliance
2. Lonza
- Specializes in custom manufacturing and distribution of APIs and intermediates
- Known for rigorous quality standards and global reach
- Supports seamless supply chain management from production to downstream distribution
Emerging and Alternative Suppliers
Given the niche status of nirogacestat hydrobromide, alternative suppliers primarily include specialized chemical synthesis CROs and CDMOs. These firms can provide flexible synthesis routes, particularly during early clinical phases or for cost-effective manufacturing.
- Almac Group: Focused on early-phase API synthesis with scalable capacities.
- Suzhou Pharma Tech: Chinese firm with competence in small-molecule APIs.
- Bachem: Known for peptide synthesis but increasingly active in small-molecule APIs.
Key Considerations in Supplier Selection
- Regulatory Compliance: Ensuring suppliers meet GMP standards, especially for APIs destined for clinical trials and eventual regulatory approval.
- Quality Assurance: Validation, stability, and analytical control measures are critical.
- Manufacturing Scale & Flexibility: Capacity to accommodate clinical demand and potential commercialization.
- Geographical Diversification: To mitigate supply chain disruptions, procurement from multiple suppliers across different regions is advisable.
- Cost & Lead Times: Balancing quality with economical production and timely delivery.
Strategic Implications for Stakeholders
Pharmaceutical companies seeking nirogacestat hydrobromide must prioritize establishing partnerships with diverse suppliers capable of meeting quality, regulatory, and capacity requirements. Given the compound’s investigational status, flexibility in early manufacturing stages is essential, with plans for scale-up aligned with clinical progress and market forecasts.
Engaging with established CDMOs such as WuXi AppTec, or leveraging large-scale manufacturers like Catalent, offers strategic advantages in quality assurance and supply reliability.
Key Takeaways
- The supply chain for nirogacestat hydrobromide involves a mix of global and regional manufacturers, with Catalent and WuXi AppTec as primary contenders for clinical and commercial supply.
- Chinese firms like Zhejiang Medicine are integral players, offering cost-effective manufacturing options aligned with international standards.
- Robust distribution partnerships with firms like Thermo Fisher and Lonza ensure end-to-end supply chain resilience.
- Supplier selection should prioritize regulatory compliance, capacity, and geographical diversification to mitigate risks.
- As nirogacestat progresses through clinical development, establishing flexible, scalable manufacturing partnerships will be critical for commercialization success.
FAQs
1. Who are the leading manufacturers of active pharmaceutical ingredient (API) for nirogacestat hydrobromide?
Leading potential API manufacturers include Catalent, WuXi AppTec, Zhejiang Medicine, and emerging CROs like Almac Group, leveraging their expertise in small-molecule synthesis under GMP standards.
2. Are there regional differences in suppliers for nirogacestat hydrobromide?
Yes, Chinese manufacturers such as Zhejiang Medicine provide cost-effective, large-scale production, while Western firms like Catalent and WuXi offer high-quality, regulated manufacturing tailored for clinical and commercial needs.
3. How does supplier selection impact clinical development of nirogacestat?
Reliable suppliers ensure consistent quality and timely delivery, which are critical for maintaining the clinical trial schedule and regulatory compliance, thereby impacting overall development timelines.
4. What factors influence the choice between different suppliers for nirogacestat hydrobromide?
Considerations include regulatory compliance, manufacturing capacity, cost, geographic location, quality control standards, and the supplier’s ability to scale with development phases.
5. What is the future outlook for supply chain partnerships for nirogacestat hydrobromide?
As the compound advances toward commercialization, strategic partnerships with scalable, compliant manufacturing firms will become increasingly vital, emphasizing diversification and contingency planning in the supply chain.
Sources
[1] Catalent Pharma Solutions – https://www.catalent.com/
[2] Zhejiang Medicine Co., Ltd. – http://www.zjmgb.com/
[3] WuXi AppTec – https://www.wuxiapptec.com/
[4] Lonza Group – https://www.lonza.com/
[5] Thermo Fisher Scientific – https://www.thermofisher.com/
[6] Bachem – https://www.bachem.com/
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