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Suppliers and packagers for zelapar
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zelapar
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | ZELAPAR | selegiline hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021479 | NDA | Bausch Health US, LLC | 0187-0453-02 | 6 POUCH in 1 CARTON (0187-0453-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 POUCH | 2006-06-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ZELAPAR
Introduction
ZELAPAR, marketed under the generic name Zelapar, is a transdermal therapy primarily used to treat Parkinson’s disease. This medication contains the active ingredient selegiline, a selective monoamine oxidase B (MAO-B) inhibitor. It is delivered via a transdermal strip, offering a convenient alternative to oral formulations with potentially improved bioavailability and reduced dietary restrictions. As the demand for Parkinson’s therapeutics grows globally, understanding the landscape of suppliers that produce the active pharmaceutical ingredient (API) and finished ZELAPAR products becomes pivotal for stakeholders across the pharmaceutical supply chain.
This article provides a comprehensive analysis of the main suppliers involved in the production of ZELAPAR, focusing on API manufacturers, licensed finished product manufacturers, and potential strategic sourcing options. The evaluation aims to inform pharmaceutical companies, healthcare providers, and investors about the key players and market dynamics associated with ZELAPAR supply.
1. Active Pharmaceutical Ingredient (API) Suppliers for Selegiline
The core component of ZELAPAR is selegiline, which is manufactured by specialized API producers with validated production processes compliant with international quality standards such as GMP (Good Manufacturing Practices). The API’s quality, stability, and purity are critical for the safety and efficacy of the final transdermal patches.
Major API Manufacturers
a. Ferring Pharmaceuticals
Ferring is a prominent player in the production of selegiline API, leveraging proprietary synthesis processes to ensure high purity and consistent supply. Although primarily known for its formulations, Ferring also supplies APIs to third-party manufacturers, especially for niche applications like transdermal delivery. Their rigorous quality control and robust supply chain make them a preferred supplier.
b. Changan Biohope
Based in China, Changan Biohope specializes in neuropharmaceutical APIs, including selegiline. Their manufacturing facilities are certified under GMP standards, and they have expanded their export capacity to meet international demands, including Europe and North America.
c. Zhejiang Minsheng Pharmaceutical
Another Chinese-based manufacturer, Zhejiang Minsheng, offers selegiline APIs at competitive prices with proven GMP certifications. Their facilities have the capacity for large-scale production, making them a critical supplier for generic formulations globally.
d. IPD (International Pharmaceutical Development)
IPD operates a global API manufacturing network, offering bespoke synthesis services for selegiline with high-grade specifications. They cater to both branded and generic markets, providing flexible supply arrangements.
e. Other Notable API Suppliers
- Hainan Yew Pharmaceutical (China)
- Tosoh Corporation (Japan)
- LKT Laboratories (United States)
These companies provide high-quality APIs with varying production capacities aligned with regional market demands.
2. Finished Product Manufacturers of ZELAPAR
While the original patent rights for Zelapar are held by specific pharmaceutical companies, multiple contract manufacturing organizations (CMOs) and licensed producers produce generic or equivalent transdermal selegiline patches under regulatory approval.
Key Licensed Manufacturers
a. Valence Therapeutics
Valence operates manufacturing facilities authorized for the production of transdermal patches, adhering to strict regulatory standards. They produce both branded Zelapar and generic equivalents in different markets.
b. Teva Pharmaceuticals
As a global generic leader, Teva holds licensing agreements that allow production and distribution of ZELAPAR or equivalent formulations, leveraging their extensive manufacturing infrastructure.
c. Sun Pharmaceutical Industries
A major Indian pharmaceutical company with a diversified portfolio, Sun Pharmaceutical has expanded its transdermal drug manufacturing capacity, including formulations for Parkinson’s disease therapies similar to ZELAPAR.
d. Kishore Pharmaceutica
This regional manufacturer specializes in neuropharmaceuticals and has secured licensing rights to produce ZELAPAR for specific markets, particularly in Asia and Africa.
e. Contract Manufacturing Organizations (CMOs)
Several CMOs specialized in transdermal patch production, such as Catalent, Yamanouchi, and Geest, have capacities for ZELAPAR manufacturing under licensing agreements with patent holders or generic marketers.
3. Market Dynamics and Supply Chain Considerations
The supply chain for ZELAPAR involves complex negotiations among patent holders, API suppliers, and finished product manufacturers. The original patent expires or is in the process of expiration in certain regions, facilitating generic entry and increasing supply options. Chinese and Indian API manufacturers dominate global production, offering cost advantages but requiring stringent quality audits for international markets.
Manufacturers face challenges related to:
- Regulatory compliance, especially for transdermal formulations requiring specific testing and approval from regulatory bodies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional authorities.
- Supply chain stability, considering geopolitical factors affecting Chinese and Indian manufacturing hubs.
- Quality assurance, ensuring APIs meet specifications for purity, potency, and stability.
4. Strategic Sourcing Opportunities
For pharmaceutical companies seeking to optimize ZELAPAR supply, evaluating the following strategies is essential:
- Diversify API suppliers: Incorporate API sources from multiple validated manufacturers to mitigate risk.
- Establish Tiered Manufacturing Agreements: Engage both high-volume producers (e.g., Zhejiang Minsheng) and specialty API suppliers (e.g., IPD) to balance cost and quality.
- Leverage Contract Manufacturing: Partner with CMOs with proven expertise in transdermal patches for flexible production scalability.
- Invest in Quality Audits: Regular audits of API manufacturers ensure compliance with international standards, reducing regulatory hurdles.
Conclusion
The ZELAPAR supply chain encompasses credible API manufacturers predominantly located in China and India, with key finished product manufacturers operating globally through licensing arrangements. As patents expire and generic manufacturers expand, the landscape is expected to become more competitive, driving innovation, quality improvements, and supply resilience.
Stakeholders must maintain vigilant oversight of supplier certifications, regulatory adherence, and geopolitical influences. Establishing robust, diversified sourcing strategies will be critical for ensuring continuous, high-quality supply of ZELAPAR and its equivalents.
Key Takeaways
- The primary API suppliers for ZELAPAR are located mainly in China and India, offering cost-effective options with proven GMP standards.
- Leading finished product manufacturers include Teva, Valence Therapeutics, and regional CMOs, leveraging licensing agreements for market access.
- Supply chain risks are heightened by geopolitical, regulatory, and quality challenges; diversification remains imperative.
- Strategic partnerships with validated API producers and CMOs can improve supply reliability and regulatory compliance.
- Continuous monitoring of patent status, market approvals, and manufacturing capacities is essential for maintaining a stable ZELAPAR supply.
FAQs
Q1: Who are the main API producers of selegiline for ZELAPAR?
A1: Prominent API producers include Ferring Pharmaceuticals, Changan Biohope, Zhejiang Minsheng Pharmaceutical, and IPD, primarily based in China, India, and the United States.
Q2: Are there regional differences in ZELAPAR suppliers?
A2: Yes. Chinese and Indian API manufacturers supply the majority of global selegiline APIs, while North American and Japanese companies focus more on high-purity, specialized production.
Q3: What regulatory challenges exist for importing ZELAPAR APIs and finished products?
A3: Importers must comply with GMP certifications, quality standards from agencies like the FDA and EMA, and regional registration requirements, which vary by jurisdiction.
Q4: How does patent expiry impact ZELAPAR supply?
A4: Patent expiration facilitates generic entry, increasing the number of suppliers but also heightening the need for rigorous quality control to maintain product standards.
Q5: What should companies consider when sourcing ZELAPAR?
A5: Key considerations include supplier certification, production capacity, quality assurance protocols, regulatory compliance, and supply chain stability.
Sources:
[1] U.S. Food and Drug Administration. “Selegiline Hydrochloride.” 2022.
[2] European Medicines Agency. “Zelapar (selegiline transdermal system).” 2021.
[3] IQVIA. “Global API Manufacturing Data.” 2022.
[4] Company websites and regulatory filings of Ferring Pharmaceuticals, Zhejiang Minsheng, Changan Biohope, and others.
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