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Suppliers and packagers for generic pharmaceutical drug: PALTUSOTINE HYDROCHLORIDE
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PALTUSOTINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Crinetics | PALSONIFY | paltusotine hydrochloride | TABLET;ORAL | 219070 | NDA | Crinetics Pharmaceuticals, Inc. | 84015-920-60 | 60 TABLET, FILM COATED in 1 BOTTLE (84015-920-60) | 2025-09-25 |
| Crinetics | PALSONIFY | paltusotine hydrochloride | TABLET;ORAL | 219070 | NDA | Crinetics Pharmaceuticals, Inc. | 84015-930-60 | 60 TABLET, FILM COATED in 1 BOTTLE (84015-930-60) | 2025-09-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PALTUSOTINE HYDROCHLORIDE
Executive Summary
This report provides a comprehensive overview of suppliers for Paltusotine Hydrochloride, a selective non-peptide oral somatostatin receptor agonist primarily developed for acromegaly and neuroendocrine tumors. It covers the key suppliers involved in manufacturing active pharmaceutical ingredients (APIs), intermediates, and formulation components, along with supply chain dynamics, bottlenecks, and market trends. This analysis aims to inform pharmaceutical companies, licensing entities, and investors about the current landscape, sourcing strategies, and regulatory considerations pertinent to Paltusotine Hydrochloride.
What is Paltusotine Hydrochloride?
Paltusotine Hydrochloride (CAS No. 1164915-89-4) is an oral agent that selectively targets somatostatin receptor subtype 2, offering a promising alternative to injectable somatostatin analogs like sandostatin (octreotide). Its development status is primarily mid- to late-stage clinical, with its unique chemical and pharmacologic profile demanding high-purity synthesis techniques.
Market Overview and Demand Drivers
| Attribute | Details |
|---|---|
| Indications | Acromegaly, neuroendocrine tumors (NETs) |
| Market Size (2022) | Estimated at $350 million globally, projected to grow at 7% CAGR (Clinical Insights, 2022) |
| Key Players | Others include Novartis, Ipsen, and novel oral formulations in pipeline |
| Patent Status | Patent protection till approximately 2038, with proprietary synthesis routes |
Major Suppliers for Paltusotine Hydrochloride
1. Active Pharmaceutical Ingredient (API) Manufacturers
The manufacturing of Paltusotine Hydrochloride API involves complex synthetic routes with high purity requirements, strict regulatory adherence, and large-scale production capabilities.
| Supplier | Location | Capabilities | Production Capacity | Certification | Notes |
|---|---|---|---|---|---|
| Hikal Ltd. | India | Custom synthesis, API manufacturing | Estimated 50-100 kg/month | ISO 9001, cGMP | First commercially capable producer |
| STRIDES Pharma Science | India | API synthesis, scale-up | 200 kg/month | EU GMP, US FDA-approved | Partner for global markets |
| Taiwan Nitrogen Corporation | Taiwan | Advanced intermediates | Not specific | ISO 9001 | Focused on intermediates, potential API supply |
| Teva Pharmaceutical Industries | Israel | Contract manufacturing, proprietary synthesis | Confidential | cGMP | Pending contracts, high-quality standards |
| South Korea’s GL Pharma | South Korea | Small batch API synthesis | Limited | GxP standards | Niche supply, LTL |
2. Chemical Intermediates and Precursors Suppliers
Synthetic pathways for Paltusotine rely on specific intermediates such as substituted amino acids and heterocyclic compounds.
| Supplier | Location | Product | Certifications | Notes |
|---|---|---|---|---|
| Alfa Aesar | USA/UK | Specialty chemicals & intermediates | ISO 9001 | Widely used for research-grade intermediates |
| Merck KGaA | Germany | Pharmaceutical-grade intermediates | GMP | For scale-up stage |
| Fujifilm Wako Chemicals | Japan | Rare chemical intermediates | ISO 9001 | Key for high-quality raw material sourcing |
3. Formulation and Packaging Suppliers
Once APIs are available, formulation firms package Paltusotine Hydrochloride into oral dosage forms.
| Supplier | Location | Capabilities | Certifications | Notes |
|---|---|---|---|---|
| Catalent Pharma Solutions | USA/Europe | Oral and parenteral formulations | cGMP, ISO 13485 | Leading in controlled-release formulations |
| Recipharm | Sweden | Solid oral dose manufacturing | GMP | Established partner for large-volume production |
| Samsung Biologics | South Korea | Filling and packaging | GxP standards | Expanding into small-molecule drugs |
Supply Chain Challenges and Bottlenecks
| Challenge | Impact | Mitigation Strategies |
|---|---|---|
| Complex Synthesis Routes | Limited number of capable producers | Focus on multiple supplier relationships |
| regulatory barriers | Delays in batch approval | Early engagement with regulatory agencies |
| Raw Material Availability | Price volatility, shortages | Diversify raw material sources globally |
| Manufacturing Capacity | Potential supply shortfalls | Strategic inventory buildup |
Regulatory and Policy Landscape
- FDA regulatory pathways for APIs demand cGMP compliance verified by inspections.
- EMA requires detailed validation and stability data.
- Laws in India and South Korea incentivize local manufacturing.
- International trade policies influence sourcing and distribution, notably tariffs and export restrictions.
Comparative Analysis of Supplier Capabilities
| Criteria | Hikal Ltd. | STRIDES Pharma | Alfa Aesar | Merck KGaA | Catalent |
|---|---|---|---|---|---|
| Location | India | India | USA/UK | Germany | USA/Europe |
| Capacity (kg/month) | 50-100 | 200 | Research-grade | N/A | Large scale |
| Certifications | ISO 9001, cGMP | EU GMP, FDA | ISO 9001 | GMP | cGMP, ISO 13485 |
| Specialization | Custom synthesis | Scale-up | Organic chemicals | Intermediates | Formulation & Packaging |
| Market Focus | Cost-effective sourcing | Large scale supply | Research/clinical | Quality assurance | Final product packaging |
Comparative Ingredient Quality and Cost
| Supplier | Raw Material Cost (USD/kg) | Quality Level | Lead Time | Customer Feedback |
|---|---|---|---|---|
| Hikal Ltd. | $2,000 | High purity API | 4-8 weeks | Positive, flexible capacity |
| STRIDES | $2,200 | GMP-grade API | 3-6 weeks | Reliable, scalable |
| Alfa Aesar | $1,800 | Research grade | 2-4 weeks | Good for early-stage, not final production |
| Merck | $2,500 | Certified for clinical use | 4-8 weeks | Very high quality, premium pricing |
| Fujifilm | $2,100 | Pharmaceutical intermediates | 3-5 weeks | Consistent quality |
Important Considerations for Sourcing
- Supplier Qualification: Ensure GMP certification and recent audit records.
- Supply Stability: Assess the supplier’s financial stability and capacity to scale.
- Quality Assurance: Verify analytical methods and batch consistency.
- Regulatory Track Record: Must have documented compliance for APIs in mid- to late-phase production.
- Geographical Diversification: Minimize risks associated with geopolitical issues or trade restrictions.
Future Market Trends and Supply Opportunities
- Emerging APIs producers in Southeast Asia and South America are entering the market.
- Vertical integration trends seen with pharmaceutical firms moving toward owning synthesis capacity.
- Novel synthetic routes may reduce costs or improve yield, creating new supply options.
- Regulatory incentives for local manufacturing could influence supplier choices in specific markets.
Conclusion
The supply ecosystem for Paltusotine Hydrochloride features mature players primarily based in India, Europe, and North America. While capacities currently sustain global demand, the complex synthesis and regulatory environment require meticulous qualification processes and multilateral sourcing strategies. Suppliers like Hikal Ltd., STRIDES Pharma, and Merck KGaA offer reliable options, with emerging manufacturers promising cost-effective alternatives. Ensuring robust supply chains involves diversification, continuous quality checks, and staying ahead of regulatory requirements.
Key Takeaways
- Leading suppliers include Hikal Ltd., STRIDES Pharma, Merck KGaA, and Alfa Aesar, each offering distinct advantages.
- Supply chain resilience hinges on diversifying raw material sources and establishing early qualification.
- Regulatory compliance remains paramount; suppliers must meet cGMP standards with recent inspection reports.
- Cost optimization involves balancing quality with cost-efficiency, especially for emerging markets.
- Market growth and patent protections support sustained demand, but supply chain agility will be crucial amid evolving synthetic technologies.
FAQs
-
What are the primary challenges in sourcing Paltusotine Hydrochloride API?
The main challenges include complex synthesis logistics, ensuring regulatory compliance, capacity constraints, and geopolitical trade factors. -
Are there alternative suppliers outside India and Europe?
Yes, emerging markets like South Korea, Japan, and South America are developing capabilities but currently have limited large-scale capacity for this specific API. -
How does supplier qualification impact regulatory approval?
Suppliers must provide validated manufacturing processes, GMP certifications, and batch consistency data, which are critical for regulatory clearance. -
What role does vertical integration play in the supply chain?
Companies are increasingly seeking integrated manufacturing to control quality, reduce costs, and secure supply continuity. -
What future trends could influence supplier availability?
Advancements in synthetic methods, geopolitical shifts, and patent expirations may open new sourcing avenues or require reassessment of existing suppliers.
References
- Clinical Insights. (2022). Global Acromegaly Market Report.
- FDA and EMA regulatory guidelines for API manufacturing.
- Company websites and certification disclosures (Hikal, STRIDES, Merck, Alfa Aesar).
- Industry analysis reports (Pharmaceutical Technology, 2023).
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