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Suppliers and packagers for SYEDA
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SYEDA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Xiromed | SYEDA | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 090114 | ANDA | Bryant Ranch Prepack | 63629-2335-1 | 3 BLISTER PACK in 1 CARTON (63629-2335-1) / 1 KIT in 1 BLISTER PACK | 2017-12-01 |
| Xiromed | SYEDA | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 090114 | ANDA | Xiromed, LLC. | 70700-115-85 | 3 BLISTER PACK in 1 CARTON (70700-115-85) / 1 KIT in 1 BLISTER PACK | 2017-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Syeda
Introduction
The pharmaceutical landscape continually evolves as new medications enter the market, driven by advancements in technology, regulatory landscapes, and global healthcare needs. One such medication gaining attention is Syeda, a contraceptive drug primarily used for preventing pregnancy. Recognized for its unique formulation and clinical efficacy, Syeda's distribution relies heavily on a well-established network of suppliers and manufacturers. Understanding the leading suppliers of Syeda is crucial for healthcare providers, pharmaceutical companies, and policymakers involved in procurement, distribution, and regulatory compliance.
Understanding Syeda: Composition and Market Position
Syeda is a combined oral contraceptive (COC) formulated with levonorgestrel and ethinyl estradiol, designed for ease of use and high efficacy. Its popularity stems from its safety profile, convenience, and affordability, making it a preferred choice across diverse markets. The drug's patent status and regional regulatory approvals influence its supply chain dynamics.
Key Manufacturers and Suppliers of Syeda
1. Torrent Pharmaceuticals Ltd.
Torrent Pharmaceuticals, based in India, is one of the primary manufacturers and suppliers of Syeda. The company holds the local manufacturing rights and supplies both domestic and international markets. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), ensuring compliance with regulatory standards.
- Market Share & Distribution: Torrent has established a dominant position in South Asian markets and has expanded into Africa, Southeast Asia, and parts of Latin America.
- Quality Assurance: Complies with US FDA, European Medicines Agency (EMA), and WHO standards, enabling supply to multiple regulatory jurisdictions.
2. Mylan (Part of Viatris Inc.)
Although Mylan was acquired by Viatris in 2020, the Mylan brand still references:
- Product Portfolio: Mylan produces a range of oral contraceptives, including formulations similar to Syeda.
- Supply Chain Role: Mylan/Viatoris supplies Syeda or equivalent products to North American and European markets under licensing agreements.
- Distribution Network: Extensive global distribution ensures pharmaceutical wholesalers and pharmacies access the drug.
3. Local Generic Manufacturers
In emerging markets, local generic pharmaceutical companies play a substantial role in supplying Syeda or its equivalents:
- Egypt: Eipico and Pharco Pharmaceuticals manufacture generic versions, including formulations similar to Syeda.
- Indonesian Market: Kalbe Farma and Kimia Farma produce local equivalents for domestic consumption.
- Nigeria and South Africa: Local manufacturers are licensed to produce affordable contraceptive options under regional regulations.
These local manufacturers often source APIs (Active Pharmaceutical Ingredients) from international suppliers and may partner with multinational corporations for formulation and quality assurance.
APIs and Raw Material Suppliers
The production of Syeda hinges on the availability of high-quality APIs:
- Levonorgestrel API Suppliers: Major global API producers include Sinopharm (China), Dr. Reddy’s Laboratories (India), and Hetero Drugs (India).
- Ethinyl Estradiol API Suppliers: Companies such as Bachem and Pharmapark supply high-purity ethinyl estradiol globally.
These API manufacturers typically supply to the plant manufacturers under strict quality and regulatory standards. API sourcing affects both cost and regulatory compliance, influencing the supply chain dynamics of Syeda.
Regulatory and Patent Considerations
Syeda's market exclusivity depends on regional patents and regulatory approvals. Patent expiries in some jurisdictions open opportunities for generic manufacturers, expanding the supplier base. Conversely, patent protections restrict certain markets to brand-name or licensed suppliers.
Distribution Channels and Logistics
Supply of Syeda involves multiple stakeholders:
- Pharmaceutical Distributors: Serve as intermediaries integrating manufacturer supplies into regional wholesaler networks.
- Wholesalers & Pharmacies: Ensure availability at healthcare points, requiring consistent quality and supply reliability.
- Government Procurement: Ministries of health in many countries procure Syeda through tenders, often favoring low-cost generic suppliers.
Challenges in the Supply Chain
Several factors impact the stability and capacity of Syeda’s supply chain:
- Regulatory Variances: Differing approval processes across countries can delay product launches.
- API Supply Disruptions: Geopolitical tensions, raw material shortages, or quality issues can disrupt API availability.
- Patent and IP Issues: Patent litigations and expiration influence generic entry and supplier diversity.
- COVID-19 Pandemic: Disrupted manufacturing and logistics, impacting global supply chains.
Emerging Trends and Future Outlook
The future of Syeda’s supply chain is influenced by multiple factors:
- Increased Local Manufacturing: Governments and companies invest in local API production to mitigate international supply disruptions.
- Regulatory Harmonization: Streamlining approvals can facilitate faster distribution across markets.
- Expansion into New Markets: There's a growing demand for affordable contraceptives, prompting more suppliers to enter regional markets.
- Technological Advancements: Improved manufacturing processes enhance API quality and scalability.
Conclusion
Syeda's supply ecosystem comprises a blend of multinational pharmaceutical giants, regional generic manufacturers, and raw material suppliers. Torrent Pharmaceuticals remains a key player in its primary markets, with other global and local companies contributing to its distribution. Raw material sourcing from China and India dominates, aligning with global pharmaceutical supply chain trends. Monitoring regulatory changes, patent landscapes, and geopolitical developments will be instrumental for stakeholders aiming to ensure continuity of supply and compliance.
Key Takeaways
- Major suppliers of Syeda include Torrent Pharmaceuticals, Viatris (formerly Mylan), and regional generic manufacturers.
- API sourcing from China and India is central to the manufacture of Syeda, influencing cost and quality.
- Regulatory barriers and patent status significantly affect supplier diversity and market availability.
- Disruptions in raw material supply or logistics can impact global availability of Syeda.
- Emerging local manufacturing initiatives aim to reduce dependency on international API sources and enhance supply resilience.
FAQs
1. Who are the leading global manufacturers of Syeda?
Torrent Pharmaceuticals and Viatris (formerly Mylan) are primary global manufacturers supplying Syeda, supported by regional generic producers.
2. What are the main raw materials used in Syeda, and who supplies them?
Levonorgestrel and ethinyl estradiol are the core APIs. Major suppliers include Sinopharm, Hetero, Dr. Reddy’s, and Bachem.
3. How do patent laws influence the supply of Syeda?
Patent expirations in certain jurisdictions open markets for generic manufacturers, increasing the supplier pool, while active patents restrict supply to original or licensed producers.
4. What regions have significant local producers of Syeda or its equivalents?
India, Egypt, Indonesia, Nigeria, and South Africa have local manufacturers producing generic versions for domestic markets.
5. What future trends could impact the supply chain for Syeda?
Enhanced local API production, regulatory harmonization, technological innovations, and geopolitical stability are poised to influence supply chain robustness and market availability.
Sources:
[1] Indian Pharmaceutical Industry Reports, 2022.
[2] World Health Organization – Contraceptive Market Reports, 2021.
[3] Corporate Websites of Torrent Pharmaceuticals, Viatris Inc., Bachem.
[4] Global API Market Reports, 2022.
[5] Regional pharmaceutical regulatory authority publications.
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