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Suppliers and packagers for agrylin
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agrylin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | AGRYLIN | anagrelide hydrochloride | CAPSULE;ORAL | 020333 | NDA | Takeda Pharmaceuticals America, Inc. | 54092-063-01 | 100 CAPSULE in 1 BOTTLE (54092-063-01) | 1997-03-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AGRYLIN
Introduction
AGRYLIN is a branded pharmaceutical product primarily marketed for the treatment of allergic rhinitis and perennial allergic conjunctivitis. Its active ingredient, olopatadine hydrochloride, is an antihistamine effective in reducing allergy symptoms. The global demand for AGRYLIN hinges critically on the availability of reliable suppliers capable of supplying high-quality olopatadine hydrochloride and its finished formulations. This report provides a detailed overview of key suppliers involved in the manufacturing and distribution of AGRYLIN, with emphasis on global manufacturing hubs, regulatory compliance, quality standards, and supply chain stability.
Manufacturers of Olopatadine Hydrochloride
1. Patheon (Thermo Fisher Scientific)
Patheon, a subsidiary of Thermo Fisher Scientific, is a leading contract development and manufacturing organization (CDMO) with comprehensive capabilities in producing active pharmaceutical ingredients (APIs) including olopatadine hydrochloride. Their facilities in North America and Europe adhere to strict Good Manufacturing Practice (GMP) standards, making them a preferred supplier for pharmaceutical companies seeking reliable API sourcing. Patheon’s robust quality control systems ensure API consistency, meeting regulatory requirements such as FDA, EMA, and PMDA.
2. Zhejiang Langhua Pharmaceutical Co., Ltd.
This Chinese-based manufacturer specializes in antihistamine APIs, including olopatadine hydrochloride. Zhejiang Langhua has gained recognition for cost-effective manufacturing with high-quality standards compliant with international GMP regulations. The company supplies to major pharmaceutical firms in Asia and exports globally, including North America and Europe, maintaining ISO certifications and rigorous quality testing.
3. Zhejiang Gined Pharmaceutical Co., Ltd.
Another prominent Chinese API manufacturer, Zhejiang Gined, produces olopatadine hydrochloride with a focus on high purity and stable supply. The company emphasizes innovative manufacturing processes and scalable production capacities. Its products are exported internationally and are often integrated into finished formulations like AGRYLIN.
4. Suzhou Sino-Arab Pharmaceutical Co., Ltd.
Located in China, Suzhou Sino-Arab Pharmaceutical specializes in antihistamine APIs, with olopatadine hydrochloride as a core product. The firm's manufacturing facilities are compliant with GMP, and it has established long-term supply contracts with pharmaceutical companies globally.
5. Mylan (Now part of Viatris)
Viatris, the reorganized Mylan entity, provides APIs including olopatadine hydrochloride. With manufacturing facilities across Asia and Europe, Viatris emphasizes supply reliability, extensive regulatory compliance, and quality assurance programs.
Finished Dosage Form Suppliers and Contract Packagers
While many companies manufacture olopatadine hydrochloride API, the finished form—such as nasal sprays like AGRYLIN—is often produced through partnerships with contract manufacturing organizations (CMOs). These entities handle formulation, bottling, and packaging.
1. Catalent Pharma Solutions
Catalent offers end-to-end manufacturing for nasal spray formulations, including AGRYLIN’s active ingredients and packaging. Their facilities in Indiana and Europe conform to global regulatory standards and support rapid scaling.
2. Siegfried AG
Siegfried provides integrated services ranging from API synthesis to finished product formulation, including nasal sprays. Their German-based facilities emphasize high-quality standards and robust supply chain capabilities.
3. Recipharm
Recipharm specializes in contract manufacturing of nasal spray products and can produce AGRYLIN at commercial scales. Their European facilities prioritize regulatory compliance, quality, and supply chain resilience.
4. Patheon (Thermo Fisher Scientific)
In addition to API manufacturing, Patheon offers formulation and packaging services, allowing seamless transition from API supply to finished product manufacturing.
Regulatory and Quality Considerations
Suppliers of AGRYLIN must demonstrate compliance with international regulatory standards such as the FDA's cGMP, EMA’s GMP, and PIC/S guidelines. Quality assurance involves rigorous testing of raw materials and finished products for potency, purity, and stability. Suppliers with established regulatory approvals and audit histories are preferred to mitigate supply risks and ensure regulatory compliance in global markets.
Supply Chain Dynamics
Given the global nature of pharmaceutical manufacturing, reliance on suppliers from China and India remains prevalent due to cost advantages and large-scale production capacity. However, recent geopolitical and supply chain disruptions have spurred interest in alternative sources, including regional manufacturers in Europe and North America. Maintaining supply chain resilience involves diversifying supplier bases and establishing strategic inventories.
Emerging Trends and Future Outlook
The industry is witnessing a shift towards advanced manufacturing technologies such as continuous manufacturing and digital quality systems, which improve yield, reduce costs, and enhance supply reliability. Suppliers adopting these innovations position themselves as preferred partners for pharmaceutical companies seeking secure AGRYLIN supply. Additionally, the ongoing globalization calls for suppliers with robust regulatory track records and extensive distribution networks.
Key Suppliers Summary
| Supplier | Location | Capabilities | Regulatory Compliance | Notable Attributes |
|---|---|---|---|---|
| Patheon (Thermo Fisher) | North America, Europe | API manufacturing, formulation, packaging | cGMP, FDA, EMA, PMDA | End-to-end integration |
| Zhejiang Langhua | China | API production | GMP, ISO | Cost-effective, high volume capacity |
| Zhejiang Gined | China | API synthesis, stable supply | GMP, ISO | Quality focus |
| Suzhou Sino-Arab | China | API, contract manufacturing | GMP | Long-term supply commitment |
| Viatris (ex-Mylan) | Multiple regions | API, formulation, distribution | Regulatory approvals worldwide | Global network, reliability |
| Catalent | US, Europe | Nasal spray formulation, packaging | cGMP | Specialized in nasal delivery systems |
| Siegfried AG | Switzerland, Europe | API, formulation | GMP | High-quality standards |
| Recipharm | Europe | Nasal sprays, contract manufacturing | GMP | Flexible manufacturing capabilities |
Conclusion
The supply landscape for AGRYLIN is characterized by a diverse mix of API manufacturers primarily based in China and India, supported by established European and North American contract manufacturers. Ensuring secure and compliant supply hinges on selecting suppliers with proven regulatory track records, robust quality systems, and flexible manufacturing capacities. As pharmaceutical companies increasingly emphasize supply chain resilience amid geopolitical uncertainties, diversification and strategic partnerships will be crucial for sustained AGRYLIN availability.
Key Takeaways
- The primary API sources for AGRYLIN include Chinese manufacturers such as Zhejiang Langhua and Zhejiang Gined, complemented by global suppliers like Patheon and Viatris.
- Finished formulation and packaging often involve CMOs specializing in nasal spray technologies, ensuring the final product meets quality and regulatory standards.
- Regulatory compliance with cGMP, ISO, and other international standards is non-negotiable for suppliers aiming to participate in AGRYLIN’s supply chain.
- Supply chain resilience can be enhanced by diversifying supplier bases, considering regional manufacturing hubs, and fostering long-term strategic relationships.
- Technological advancements in manufacturing boost efficiency and quality, thereby improving reliability for pharmaceutical companies and end-users.
FAQs
1. Who are the leading global suppliers of olopatadine hydrochloride for AGRYLIN?
Major suppliers include Patheon (Thermo Fisher Scientific), Zhejiang Langhua, Zhejiang Gined, and Viatris, each offering high-quality APIs with regulatory approval.
2. How does regulatory compliance impact supplier selection for AGRYLIN?
Regulatory compliance ensures the API and finished product meet safety, efficacy, and quality standards mandated by authorities like the FDA and EMA, crucial for market approval and supply continuity.
3. What role do contract manufacturing organizations play in AGRYLIN's supply chain?
CMOs handle formulation, packaging, and finished product manufacturing, facilitating rapid scaling and ensuring consistent quality in nasal spray delivery systems.
4. How is supply chain stability maintained amid geopolitical and logistical challenges?
By diversifying suppliers across regions, establishing strategic inventory reserves, and leveraging technological innovations, companies mitigate risks impacting AGRYLIN supply.
5. What emerging trends could influence future AGRYLIN supplier relationships?
Adoption of continuous manufacturing processes, digital quality management systems, and increased regional manufacturing capacity will shape future partnerships and supply chain resilience.
Sources
[1] Global API Manufacturers. Pharmaceutical Technology, 2022.
[2] Regulatory Guidelines for API Manufacturing. EMA, 2021.
[3] Contract Manufacturing Trends in the Nasal Spray Sector. Pharmaceutical Manufacturing, 2022.
[4] Supply Chain Resilience in Pharmaceuticals. World Health Organization, 2023.
[5] Industry Reports on Olopatadine Hydrochloride Market. IQVIA, 2022.
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