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Suppliers and packagers for generic pharmaceutical drug: CASPOFUNGIN ACETATE
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CASPOFUNGIN ACETATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Merck | CANCIDAS | caspofungin acetate | POWDER;INTRAVENOUS | 021227 | NDA | Merck Sharp & Dohme LLC | 0006-3822-10 | 1 VIAL, SINGLE-USE in 1 CARTON (0006-3822-10) / 10.8 mL in 1 VIAL, SINGLE-USE | 2001-01-26 |
| Merck | CANCIDAS | caspofungin acetate | POWDER;INTRAVENOUS | 021227 | NDA | Merck Sharp & Dohme LLC | 0006-3823-10 | 1 VIAL, SINGLE-USE in 1 CARTON (0006-3823-10) / 10.8 mL in 1 VIAL, SINGLE-USE | 2001-01-26 |
| Areva Pharms | CASPOFUNGIN ACETATE | caspofungin acetate | POWDER;INTRAVENOUS | 211263 | ANDA | Areva Pharmaceuticals | 59923-613-70 | 1 VIAL, SINGLE-DOSE in 1 CARTON (59923-613-70) / 10.8 mL in 1 VIAL, SINGLE-DOSE | 2021-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CASPOFUNGIN ACETATE
Overview of CASPOFUNGIN ACETATE
Caspofungin acetate is an antifungal agent belonging to the echinocandin class, primarily used to treat invasive fungal infections such as candidemia and invasive aspergillosis. It functions by inhibiting the synthesis of β-(1,3)-D-glucan, an essential component of fungal cell walls, leading to cell lysis and death. Its commercial production involves sophisticated chemical synthesis and fermentation-based manufacturing processes, making the selection of reliable suppliers crucial for pharmaceutical companies ensuring product quality, supply stability, and regulatory compliance.
Global Manufacturing Landscape
The global supply chain for caspofungin acetate predominantly hinges on a handful of well-established pharmaceutical manufacturers and specialty chemical producers. These companies are characterized by their advanced GMP-compliant facilities, robust R&D capabilities, and comprehensive regulatory approvals from agencies such as the FDA, EMA, and PMDA. The major suppliers can be broadly categorized into original innovator companies and generic manufacturing firms.
Major Suppliers of Caspofungin Acetate
1. Merck & Co., Inc.
Originator Manufacturer
Merck & Co. holds the patent rights for the original formulation of caspofungin acetate, marketed under the brand name Cancidas. As the innovator, Merck is a primary supplier for the active pharmaceutical ingredient (API) and finished dosage forms. Their production facilities are located across North America, Europe, and Asia, adhering strictly to cGMP guidelines.
Key Characteristics:
- Proven quality and consistency
- Extensive regulatory dossiers supporting global approvals
- Proven supply capacity to meet international demand
Distribution channels: Merck supplies APIs and finished products directly to licensed partners and authorized generic manufacturers worldwide.
2. Zhejiang Chuangxin Pharmaceutical Co., Ltd. (China)
Generic Manufacturer
Chuangxin Pharmaceutical is a leading Chinese API producer, specializing in antifungals and antibiotics. They have received Chinese GMP certification and are expanding their export footprint through global regulatory approvals.
Key Characteristics:
- Competitive pricing
- Focus on APIs for domestic and global markets
- License agreements with international partners
Regulatory status: Chuangxin has obtained certifications compatible with US and European standards, facilitating exports to regulated markets.
3. Hainan Zhonghe Pharmaceutical Co., Ltd.
Emerging Chinese Supplier
Zhonghe Pharmaceutical offers caspofungin acetate APIs targeting both domestic and export markets. They have invested in advanced synthesis and fermentation technology, aiming to achieve high purity standards required by international regulators.
Key Characteristics:
- Cost-effective production
- Growing presence in global supply chain
- Focused on meeting international GMP standards
Regulatory considerations: While primarily approved in China, Zhonghe is pursuing approvals in Europe and North America.
4. Beijing SL Pharmaceutical Co., Ltd.
Chinese API Producer
SL Pharmaceutical emphasizes quality manufacturing of antifungal APIs, including caspofungin acetate, with a focus on compliance with international standards, including the EU Good Manufacturing Practice (GMP).
Key Characteristics:
- Certifications: GMP, ISO
- Emphasis on scientific innovation and process optimization
- Active in exporting to global markets
Emerging and Specialty Suppliers
5. BeiJing Tiantan Biological Products Co., Ltd.
While primarily known for biological products, they are exploring development of synthetic antifungal APIs, including caspofungin acetate, leveraging their expertise in fermentation technology.
6. Other Regional Players
Numerous smaller-scale producers across India, South Korea, and Southeast Asia are increasingly investing in antifungal APIs, aiming to capture emerging markets, although regulatory clearance varies regionally.
Supply Chain Considerations
- Regulatory Approvals and Compliance: Suppliers must comply with cGMP standards and hold relevant certifications such as FDA approval, EMA GMP certification, or WHO-GMP certification to meet international requirements.
- Quality and Consistency: The complex synthesis of caspofungin acetate demands rigorous quality control, with suppliers providing detailed documentation, stability data, and third-party testing.
- Capacity and Lead Times: Given the active drug's demand in treating invasive fungal infections, manufacturers with robust capacity and reliable supply chains are prioritized.
- Pricing Dynamics: Competition among Chinese and Indian manufacturers often influences pricing, but quality and regulatory acceptance remain decisive factors for multinational pharmaceutical companies.
Challenges and Risks in Sourcing
- Regulatory Hurdles: Ensuring compliance and obtaining necessary approvals can restrict supply options.
- Intellectual Property: While the original patent held by Merck has expired or is nearing expiry in some territories, licensing agreements or patent litigation may influence the availability and licensing of generic versions.
- Quality Assurance: Variability in manufacturing processes can impact API purity and potency, underscoring the importance of rigorous audits and supplier qualification.
Market Outlook
The global antifungal market growth, driven by increasing incidence of immunosuppressed patient populations and expanding healthcare infrastructure, signifies sustained demand for caspofungin acetate. Supply chain diversification and strengthening manufacturing capabilities in emerging markets are expected to ensure more resilient sourcing options, although regulatory complexities will continue to shape the supplier landscape.
Key Takeaways
- Major suppliers of caspofungin acetate include Merck (original innovator), Chinese manufacturers like Zhejiang Chuangxin Pharmaceutical, and other regional players focused on cost-effective production.
- Ensuring supplier compliance with international GMP standards is critical for regulatory acceptance and patient safety.
- Supply chain stability depends on capacity, regulatory certifications, and technological expertise, prompting companies to engage with multiple qualified suppliers.
- Emerging markets are increasingly influential, driven by technological advances and regulatory harmonization, but quality assurance remains paramount.
- Strategic sourcing, detailed due diligence, and maintaining strong supplier relationships are essential for uninterrupted access to high-quality caspofungin acetate.
FAQs
1. Is caspofungin acetate available from multiple suppliers globally?
Yes, after patent expiration in several regions, multiple generic manufacturers, primarily in China and India, now produce caspofungin acetate, increasing supply diversity.
2. What regulatory standards should suppliers of caspofungin acetate meet?
Suppliers should comply with cGMP standards recognized by agencies such as the FDA, EMA, or WHO-GMP, ensuring pharmaceutical-grade quality.
3. How does supplier quality impact clinical outcomes?
High-quality APIs with consistent purity and potency are critical for therapeutic efficacy and safety, reducing risks related to contamination or variability.
4. Are there risks associated with sourcing from emerging markets?
Risks include regulatory variability, quality assurance challenges, and intellectual property concerns, emphasizing the need for rigorous audits and validation.
5. What factors should companies consider when selecting a caspofungin acetate supplier?
Regulatory compliance, manufacturing capacity, quality control systems, pricing, lead times, and supplier reputation are paramount considerations.
References
[1] U.S. Food and Drug Administration. "Cancidas (caspofungin) FDA approval." 2001.
[2] European Medicines Agency. "Caspofungin summary of product characteristics." 2018.
[3] Market Research Future. "Antifungal Drugs Market Analysis." 2022.
[4] Generic Pharmaceutical Association. "Quality standards for antifungal APIs." 2021.
[5] Industry reports on API manufacturing in China and India. 2022.
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