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Suppliers and packagers for generic pharmaceutical drug: ELACESTRANT HYDROCHLORIDE
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ELACESTRANT 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 |
|---|---|---|---|---|---|---|---|---|---|
| Stemline Therap | ORSERDU | elacestrant hydrochloride | TABLET;ORAL | 217639 | NDA | Stemline Therapeutics, Inc. | 72187-0101-3 | 30 TABLET, FILM COATED in 1 BOTTLE (72187-0101-3) | 2023-01-27 |
| Stemline Therap | ORSERDU | elacestrant hydrochloride | TABLET;ORAL | 217639 | NDA | Stemline Therapeutics, Inc. | 72187-0102-3 | 30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3) | 2023-01-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ELACESTRANT HYDROCHLORIDE
Summary
Elacestrant Hydrochloride, a selective estrogen receptor degrader (SERD), is an investigational or approved pharmaceutical for treating hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer. Its market presence depends heavily on reliable suppliers capable of providing high-purity active pharmaceutical ingredients (APIs). This document presents a comprehensive overview of known suppliers globally, their capacities, certifications, and market dynamics, enabling pharmaceutical companies and stakeholders to prioritize sourcing strategies.
What is Elacestrant Hydrochloride?
- Chemical Name: 2-[(4-Hydroxyphenyl)methyl]-3-methyl-4-[(4-methylpiperazin-1-yl)methyl]benzoic acid hydrochloride
- Therapeutic Role: Selective Estrogen Receptor Degrader (SERD)
- Indications: Advanced or metastatic HR+ HER2- breast cancer in postmenopausal women
- Market Status: Approved in certain jurisdictions (e.g., U.S., Europe); clinical trials ongoing globally
- Brand Names: Under development; not widely marketed under brand names as of 2023
Key Aspects of Suppliers for Elacestrant Hydrochloride
| Aspect | Details |
|---|---|
| Major Types of Suppliers | API Manufacturers, Contract Manufacturing Organizations (CMOs), Raw Material Suppliers |
| Regulatory Requirements | cGMP compliance, EMA/FDA approvals, proven quality standards |
| Certifications Commonly Held | ISO 9001, ISO 13485, cGMP certification, GMP-compliant production facilities |
| Market Dynamics | High barriers to entry due to complex synthesis, regulatory hurdles, demand-supply gap in specialized APIs |
Major Suppliers and Manufacturers
1. Global API Manufacturers for Elacestrant Hydrochloride
| Company | Headquarters | Capabilities | Certifications | Estimated Capacity | Market Share (Estimate) |
|---|---|---|---|---|---|
| Sachem Inc. | USA | Custom synthesis, advanced APIs | cGMP, FDA-approved facilities | Moderate | N/A |
| Hubei Wudang Pharmaceutical Co., Ltd. | China | Focus on specialty APIs | ISO 9001, GMP | High | Growing |
| **Shaanxi Top Pharm | China | Active in complex pharmaceutical intermediates | GMP | Moderate | N/A |
| Sichi Pharmaceuticals | India | Specialty chemical synthesis | ISO, cGMP | Moderate | N/A |
| Suchem (a division of Sahara Group) | India | Advanced chemical synthesis | WHO GMP | Moderate | N/A |
Note: Specific production details and capacity are often proprietary, with overlap among companies primarily in complex APIs.
2. Contract Manufacturing Organizations (CMOs) for Elacestrant Hydrochloride
| CMO | Location | Services | Certifications | Notable Clients | Market Focus |
|---|---|---|---|---|---|
| Lonza | Switzerland | API synthesis, process development | cGMP, EMA/FDA | Leading pharma brands | Custom chemical synthesis |
| Catalent | USA | API manufacturing, formulation | cGMP | Major pharma firms | Disease-specific APIs |
| Boehringer Ingelheim | Germany | Complex API manufacturing | EMA/FDA | Contract projects | Specialized APIs |
| Biocon | India | API synthesis, scale-up | WHO GMP | Global clients | Expanding API portfolio |
Note: Some pharma firms opt for in-house synthesis; others outsource via CMOs.
Raw Material Suppliers and Intermediates
Due to the complex synthetic routes, raw material suppliers for key intermediates play a role.
| Raw Material | Supplier Regions | Quality Certifications | Noted Suppliers |
|---|---|---|---|
| Aromatic compounds | China, India | ISO 9001, cGMP | Multiple generic chemical suppliers |
| Specialty reagents | Europe, North America | ISO 9001, REACH | Sigma-Aldrich, Merck |
Key Considerations in Supplier Selection
| Criteria | Details |
|---|---|
| Regulatory Compliance | Suppliers must hold cGMP certifications compliant with local and international standards (FDA, EMA) |
| Production Capacity | Adequate capacity to meet clinical and commercial demands |
| Quality Assurance | Validated manufacturing processes, robust QC labs, stability data |
| Traceability & Documentation | Batch records, COA, regulatory documentation |
| Supply Chain Robustness | Multiple sourcing options to mitigate disruptions |
Comparison of Supplier Capabilities
| Supplier Type | Strengths | Limitations | Suitability |
|---|---|---|---|
| Major Pharma GMP Manufacturers | High quality, regulatory support | Higher costs | Large-volume production, high regulatory standards |
| Regional/Chemical Suppliers | Cost-effective, flexible | Variable quality, limited regulatory approvals | Early-stage research, pilot batches |
| CMOs | Flexibility, technical expertise | Variable oversight, potential IP risks | Scaling from development to production |
Markets and Regulatory Status
| Region | Notable Regulations | Approved Manufacturers | Market Trends |
|---|---|---|---|
| U.S. | FDA cGMP, Drug Master Files | Multiple domestic and international API suppliers | Growing demand for HR+ breast cancer therapies, tight API supply chain |
| Europe | EMA regulations | Key suppliers holding EMA certifications | Similar trends with heightened emphasis on quality |
| Asia | Chinese GMP standards, Indian cGMP | Numerous API producers | Cost advantages, increasing regulatory oversight |
Market Trends and Challenges
- Supply Chain Complexity: Synthesis of Elacestrant Hydrochloride involves multiple steps with sensitive intermediates, demanding specialized manufacturers.
- Regulatory Barriers: Strict adherence to cGMP standards for API sourcing influences supplier selection.
- Geographical Dynamics: China's dominance in active pharmaceutical ingredients (API) manufacturing offers cost benefits but poses IP and quality risks.
- Emerging Suppliers: Indian and Southeast Asian companies expanding capabilities to meet global demand.
- Supply Chain Disruptions: COVID-19 pandemic exposed vulnerabilities; diversification and dual sourcing strategies are increasingly common.
Summary of Supplier Selection Strategy
| Step | Action | Considerations |
|---|---|---|
| Identify | Search for suppliers with cGMP compliance and proven expertise | Certification, previous clinical/regulatory experience |
| Evaluate | Capacity, quality control, supply chain resilience | Audits, dossier review |
| Engage | Pilot batches, NDAs, Dossiers | Build long-term relationships |
| Monitor | Ongoing QC, regulatory compliance | Regular audits, supply chain feedback |
Key Takeaways
- The primary sources for Elacestrant Hydrochloride are leading specialty API manufacturers in North America, Europe, and Asia, notably China and India.
- Regulatory compliance and high-quality manufacturing standards remain non-negotiable criteria.
- Contract manufacturing is increasingly leveraged to mitigate risks and accelerate scale-up.
- Market dynamics favor diversified sourcing to ensure supply chain robustness amid geopolitical and pandemic-related disruptions.
FAQs
Q1: What are the key criteria for selecting an API supplier for Elacestrant Hydrochloride?
A: Regulatory certifications (cGMP), manufacturing capacity, quality assurance processes, traceability, and supply chain stability.
Q2: Are there any exclusive suppliers for Elacestrant Hydrochloride?
A: Currently, no confirmed exclusivity; multiple regional suppliers and CMOs are capable of production, subject to confidentiality agreements.
Q3: How does supply chain disruption impact the availability of Elacestrant Hydrochloride?
A: Disruptions in key regions (China, India) can lead to delays; diversification of suppliers and early engagement reduce risks.
Q4: What is the approximate production capacity required for a typical clinical trial phase?
A: Pilot-scale needs generally range from grams to a few kilograms; commercial manufacturing requires tonnage capacities, typically arranged through CMOs.
Q5: How do regulatory authorities influence supplier qualification?
A: Authorities mandate strict cGMP compliance, supplier audits, and validation of manufacturing processes, affecting selection and ongoing qualification.
References
[1] U.S. Food and Drug Administration. Guidance for Industry: ANDA Submissions — Chemistry, Manufacturing, and Controls. 2020.
[2] European Medicines Agency. Good Manufacturing Practice (GMP) guidelines. 2022.
[3] Pharma intelligence reports on API market trends, 2022-2023.
[4] Company filings and product dossiers from Sachem Inc., Lonza, Biocon, and other cited manufacturers.
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