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Suppliers and packagers for ALOXI
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ALOXI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372 | NDA AUTHORIZED GENERIC | Cipla USA Inc. | 69097-927-35 | 1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIAL | 2018-03-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Aloxi (Palonosetron Hydrochloride)
Overview of Aloxi (Palonosetron Hydrochloride)
Aloxi, with the active pharmaceutical ingredient (API) palonosetron hydrochloride, is a potent serotonin 5-HT3 receptor antagonist primarily used for the prevention of chemotherapy-induced nausea and vomiting (CINV). Marketed by Helsinn Healthcare, Aloxi's efficacy hinges on the reliable supply of high-quality API and finished formulations. As a critical component in supportive oncology care, the procurement strategy involves an intricate network of API and finished drug suppliers globally.
Key API Suppliers for Aloxi
Leading API Manufacturers
Palonosetron hydrochloride's synthesis requires specialized manufacturing capabilities, given its complex chemical structure and strict purity standards. The leading API suppliers for Aloxi encompass several global pharmaceutical and biotech companies, with a few dominant players:
1. Mynthas Pharma
Overview:
Mynthas Pharma, based primarily in India, is recognized for producing high-quality APIs for oncology and supportive care medications, including palonosetron hydrochloride. They boast extensive GMP-compliant facilities capable of meeting international standards.
Supply Capabilities:
- API manufacturing for sterile and non-sterile compounds
- R&D pipelines for next-generation 5-HT3 antagonists
- Proven track record of supplying to global markets
Certifications:
- WHO-GMP, USFDA, EMA compliance
2. Shanghai Sunve Pharmaceutical Co., Ltd.
Overview:
A leading Chinese API manufacturer with robust R&D and manufacturing infrastructure, Shanghai Sunve supplies pharmacopeia-grade palonosetron hydrochloride. Its strategic location allows cost-efficient production and supply chain management, especially for Asian markets.
Supply Capabilities:
- Large-scale manufacturing aligned with international quality standards
- Ability to scale production based on demand cycles
Certifications:
- GMP, Chinese FDA approval, and certifications aligned with international standards
3. Hanlim Pharmaceutical Co., Ltd.
Overview:
South Korea's Hanlim Pharmaceutical specializes in high-end APIs used in oncology treatments. The company has developed a reputation for producing stable, high-purity palonosetron hydrochloride suitable for injectable formulations.
Supply Capabilities:
- Extensive experience in sterile API production
- Custom synthesis options for specific formulations
Certifications:
- KFDA, cGMP, ISO 9001
4. Camber Pharmaceuticals
Overview:
Based in the United States, Camber Pharmaceuticals manufactures generic APIs and finished formulations. Its portfolio includes oncology support drugs, with recent investments targeting palonosetron API.
Supply Capabilities:
- U.S.-based manufacturing with high regulatory oversight
- Supply chain agility for North American markets
Certifications:
- FDA-approved facilities, ISO compliance
5. Huadong Medicine Co., Ltd.
Overview:
A China-based pharmaceutical group, Huadong Medicine produces APIs including palonosetron hydrochloride, primarily serving Asian markets beyond Chinese borders.
Supply Capabilities:
- Large production capacities with focus on quality control
- Integration with downstream formulation facilities
Certifications:
- GMP, Chinese FDA
Finished Formulation Suppliers
In addition to API manufacturers, several pharmaceutical companies produce aloxi formulations, often sourcing APIs from the above suppliers:
1. Helsinn Healthcare SA
Role:
Original developer and global marketer of Aloxi. For global regions excluding the US, Helsinn licenses production to approved manufacturers, ensuring availability and quality.
2. SCP Pharma
Overview:
A European manufacturer supplying Aloxi in various markets, often using sourced APIs from licensed suppliers. SCP emphasizes quality assurance and regulatory compliance.
3. Local Generics Manufacturers
In emerging markets, local firms often produce Aloxi under licenses or as generics, sourcing APIs from regional suppliers—primarily Chinese and Indian manufacturers.
Supply Chain Considerations for Aloxi
Regulatory Compliance and Certification
Suppliers must uphold stringent quality standards, adherence to Good Manufacturing Practices (GMP), and compliance with regional regulatory authorities such as the US FDA, EMA, Chinese NMPA, and Japanese PMDA. Certification ensures API purity, safety, and efficacy.
Supply Security and Risk Mitigation
Given the critical nature of Aloxi in oncology care, companies seek diversified supplier bases. This minimizes risks from geopolitical tensions, supply chain disruptions, or quality issues with a single source.
Pricing and Market Dynamics
API costs from Indian and Chinese manufacturers typically offer cost advantages, influencing procurement strategies for multinational pharmaceutical firms. However, quality assurance remains paramount, especially for injectable drugs.
Conclusion
The supply landscape for Aloxi's API and formulations involves a select group of globally recognized manufacturers renowned for their quality, regulatory compliance, and manufacturing capacity. Key API suppliers like Mynthas Pharma, Shanghai Sunve, Hanlim Pharmaceutical, Camber Pharmaceuticals, and Huadong Medicine constitute the backbone of the Aloxi supply chain. Strategic sourcing, coupled with rigorous quality control and diversified supplier relationships, underpins the steady availability of this essential oncology supportive care drug.
Key Takeaways
- Dominant API Suppliers: Several global players, especially in India, China, South Korea, and the USA, supply palonosetron hydrochloride API for Aloxi, each with robust manufacturing capabilities and certifications.
- Quality and Compliance: Ensuring API sources meet international standards (GMP, FDA, EMA) is essential due to Aloxi's critical clinical role.
- Supply Chain Diversification: Pharmaceutical companies prioritize multiple sourcing options to mitigate risks associated with supply disruptions.
- Cost vs. Quality Balance: Indian and Chinese manufacturers provide competitive pricing but must be vetted thoroughly for regulatory compliance.
- Regulatory Landscape: Strict adherence to documentation, certifications, and audit requirements is necessary to maintain supply continuity for global markets.
Frequently Asked Questions (FAQs)
1. Who are the main API manufacturers for Aloxi (palonosetron hydrochloride)?
Primary API suppliers include Mynthas Pharma, Shanghai Sunve Pharmaceutical, Hanlim Pharmaceutical, Camber Pharmaceuticals, and Huadong Medicine, each recognized for quality manufacturing and regulatory compliance.
2. How does regulatory approval impact supplier selection for Aloxi?
Suppliers must possess GMP certifications and approvals from agencies like the US FDA, EMA, or NMPA to ensure API quality, safety, and market access.
3. Are Chinese and Indian manufacturers reliable sources for Aloxi API?
Yes. Many Indian and Chinese manufacturers are WHO-GMP and USFDA-approved. However, thorough due diligence and audits are recommended for quality assurance.
4. What are the risks associated with sourcing Aloxi API from a single supplier?
Relying on a sole source increases supply vulnerability to disruptions, regulatory issues, or quality deficiencies. Diversification mitigates such risks.
5. How do market dynamics influence the pricing of Aloxi API?
Cost-effective manufacturing in India and China influences competitive drug pricing, but quality and regulatory adherence are non-negotiable considerations.
Sources:
- Helsinn Group. "Aloxi (palonosetron hydrochloride) prescribing information."
- Global pharmaceutical APIs market reports for oncology drugs.
- US FDA, EMA, and Chinese NMPA certification databases.
- Industry intelligence from API manufacturer websites and annual reports.
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