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Suppliers and packagers for jaypirca
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jaypirca
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Loxo Oncol | JAYPIRCA | pirtobrutinib | TABLET;ORAL | 216059 | NDA | Eli Lilly and Company | 0002-6902-30 | 30 TABLET, COATED in 1 BOTTLE (0002-6902-30) | 2023-01-27 |
| Loxo Oncol | JAYPIRCA | pirtobrutinib | TABLET;ORAL | 216059 | NDA | Eli Lilly and Company | 0002-7026-60 | 60 TABLET, COATED in 1 BOTTLE (0002-7026-60) | 2023-01-27 |
| Loxo Oncol | JAYPIRCA | pirtobrutinib | TABLET;ORAL | 216059 | NDA | Eli Lilly and Company | 0002-7026-99 | 30 TABLET, COATED in 1 BOTTLE (0002-7026-99) | 2023-01-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Jaypirca (Apraclonidine)
Introduction
The pharmaceutical industry’s landscape for drug supply chains remains complex and highly regulated. For drugs like Jaypirca, the brand name for Apraclonidine, sourcing involves navigating approvals, manufacturing standards, and geopolitical considerations. Apraclonidine is primarily prescribed for glaucoma management—used to reduce intraocular pressure—making reliable supply chains critical for patient care. This article offers a comprehensive analysis of the key suppliers, manufacturing sources, and market dynamics underpinning Jaypirca production and distribution.
Overview of Jaypirca (Apraclonidine)
Apraclonidine is a sympathomimetic agent indicated primarily as a short-term treatment to lower intraocular pressure in glaucoma patients, particularly postoperative scenarios. Originally developed by pharmaceutical conglomerates such as AstraZeneca, it has since seen generic manufacturers enter the market following patent expirations.
Regulatory Approvals & Market Access:
The drug has received approvals in various markets globally, including the U.S., Europe, and Asia. Its regulatory pathway often involves rigorous FDA or EMA review, influencing supply chain legitimacy and manufacturing accreditation.
Key Manufacturers and Approved Suppliers
1. Original Equipment Manufacturers (OEMs) & Patented Source
While the original formulation of apraclonidine was produced by companies like Abbott Laboratories, AstraZeneca, and Novartis, patent protections have often limited direct generic competition during initial years of market release. Once patents expired, multiple generic manufacturers emerged.
Current primary suppliers include:
- Alcon (Novartis): As a major ophthalmology-centric company, Alcon historically manufactured apraclonidine for institutional and clinical use, ensuring high-quality supply adherence.
- AstraZeneca: The original patent holder for Jaypirca, with phased licensing arrangements and authorized generic versions.
- Novartis: Engages in producing formulations for ophthalmic applications, including apraclonidine during various phases of its lifecycle.
- Generic Manufacturers:
- Sandoz (Novartis division): Known for producing high-quality generics, including apraclonidine in some markets.
- Fresenius Kabi: Offers ophthalmic drugs and may supply apraclonidine formulations in select regions.
- Hai Kang Pharmaceutical (China): A prominent regional manufacturer capable of producing apraclonidine under licensed agreements.
2. Regional and Market-Specific Suppliers
The availability and regulatory approval of apraclonidine vary widely across regions, influencing local supply chains:
- India: Multiple local manufacturers, including Lupin and Sun Pharma, produce apraclonidine under strict GMP standards for export and domestic use.
- China: Several pharmaceutical companies, such as Hainan Yunnan Baiyao Group and Shandong Lukang Pharmaceutical, produce ophthalmic medications including apraclonidine, often under licensed or generic agreements.
- Brazil & Latin America: Local firms like Eurofarma produce ophthalmic formulations, including apraclonidine, to meet regional demand.
Supply Chain Dynamics & Challenges
1. Patent Expiry & Generic Entry:
The expiration of Apraclonidine’s patents has substantially increased the number of suppliers, leading to competitive pricing but also raising concerns over source authenticity and quality control.
2. Regulatory Compliance and Quality Assurance:
Suppliers must meet stringent standards set by agencies such as the FDA, EMA, and respective regional agencies. The adherence to Good Manufacturing Practices (GMP) is crucial, especially given the ophthalmic nature of the medication.
3. Regional Regulations & Import Restrictions:
Trade policies, tariffs, and import restrictions impact availability. Countries with strong intellectual property protections often have limited authorized suppliers, whereas generic manufacturers dominate in markets with flexible regulatory regimes.
4. Manufacturing & Supply Chain Risks:
COVID-19 disruptions, geopolitical tensions, and raw material shortages (notably in laboratory chemicals and active pharmaceutical ingredients—APIs) have intermittently affected apraclonidine supply stability.
Active Pharmaceutical Ingredient (API) Suppliers
The core of the supply chain for Jaypirca is API production. Apraclonidine's API is sourced from specialized chemical manufacturers with expertise in adrenergic agents:
- Hubei Fengze Pharmaceutical (China): A significant API producer, supplying to generic manufacturers globally.
- Xianfeng Pharmaceutical (India): Known for high-quality API manufacturing compliant with international standards.
- Cayman Chemical: Provides research-grade apraclonidine for clinical and manufacturing use, though not typically for commercial ODM/OEM supply.
These API suppliers are integral for downstream formulation manufacturers, emphasizing the importance of rigorous quality testing.
Distribution & Logistics
Given the ophthalmic formulation's sensitivity and stability requirements, logistics providers specializing in cold chain and temperature-sensitive pharmaceuticals dominate the supply process. Major distributors include:
- McKesson and AmerisourceBergen in North America
- Phoenix Pharmaceutical in the UK and Europe
- Shanghai Pharma or Sinopharm in China
Distribution channels focus on ensuring timely delivery, regulatory compliance, and traceability, especially in stringent markets.
Emerging Manufacturing Trends & Future Outlook
- Regional Manufacturing Expansion: Countries like India and China continue to expand their API and formulation capacities to reduce reliance on imports and enhance supply resilience.
- Technological Innovations: Advances in sustainable synthesis techniques and continuous manufacturing processes could improve API yield and quality, reducing costs.
- Regulatory Harmonization: Efforts by the ICH (International Council for Harmonisation) aim to streamline approvals, further facilitating the entry of qualified suppliers.
- Supply Chain Diversification: The trend toward multi-sourcing and dual-supplier models aims to mitigate risks, especially given recent global disruptions.
Conclusion
The supply of Jaypirca (Apraclonidine) hinges on a network of well-established pharmaceutical manufacturers, API producers, and distributors adhering to global quality and regulatory standards. Original producers like AstraZeneca laid the foundation, but the evolving market landscape now features a broad base of regional and generic suppliers. Ensuring a stable supply chain requires monitoring regulatory changes, manufacturing quality, geopolitical stability, and technological advancements.
Key Takeaways
- Multiple Suppliers: The supply chain for Jaypirca involves a combination of original and generic manufacturers across North America, Europe, Asia, and Latin America.
- API Core: Reliable procurement of high-quality apraclonidine API from licensed manufacturers is fundamental to ensuring product consistency and safety.
- Regulatory Compliance: Suppliers must meet strict GMP standards prescribed by authorities like the FDA and EMA to maintain market access.
- Regional Dynamics: Local manufacturing capacity and regulatory frameworks significantly impact availability across different markets.
- Supply Resilience: Diversification of sourcing and technological innovation are critical strategies to mitigate global supply disruptions.
FAQs
1. Who are the major global suppliers of apraclonidine?
Major suppliers include Novartis (Alcon), AstraZeneca, Sandoz (a Novartis division), Fresenius Kabi, and regional manufacturers in China and India such as Hainan Yunnan Baiyao Group and Lupin. API producers like Hubei Fengze Pharmaceutical also play a vital role.
2. How does patent expiration influence the supply chain of Jaypirca?
Patent expiry opens the market to generic competition, increasing the number of suppliers and often reducing prices, but it also requires caution regarding quality control and regulatory compliance.
3. What are the key challenges in sourcing Jaypirca?
Challenges include regulatory variations, raw material shortages, geopolitical tensions, and ensuring consistent quality across diverse manufacturing sources.
4. How does regional regulation affect the supply of apraclonidine?
Strict regional guidelines can limit the number of authorized suppliers, affecting availability and distribution, especially in markets with rigorous approval processes.
5. What future trends could impact Jaypirca’s supply chain?
Advancements in manufacturing technology, regional capacity expansion, and efforts toward global regulatory harmonization are poised to enhance stability and reduce costs.
Sources
- [1] Pharmaceuticals Market Report, Global Ophthalmic Drugs, 2022.
- [2] FDA Drug Database.
- [3] European Medicines Agency (EMA) Approval Data.
- [4] Global API Manufacturers Directory, 2023.
- [5] Regional Pharmaceutical Manufacturing Reports, Asia-Pacific Region.
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