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Suppliers and packagers for mono-linyah
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mono-linyah
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novast Labs Ltd | MONO-LINYAH | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090523 | ANDA | Northstar Rx LLC | 16714-360-01 | 1 BLISTER PACK in 1 PACKET (16714-360-01) / 1 KIT in 1 BLISTER PACK | 2012-05-23 |
| Novast Labs Ltd | MONO-LINYAH | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090523 | ANDA | Northstar Rx LLC | 16714-360-02 | 1 BLISTER PACK in 1 CARTON (16714-360-02) / 1 KIT in 1 BLISTER PACK | 2012-05-23 |
| Novast Labs Ltd | MONO-LINYAH | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 090523 | ANDA | Northstar Rx LLC | 16714-360-03 | 3 BLISTER PACK in 1 CARTON (16714-360-03) / 1 KIT in 1 BLISTER PACK | 2012-05-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MONO-LINYAH
Introduction
MONO-LINYAH is a proprietary pharmaceutical product marketed primarily as an oral contraceptive. Its formulation typically contains a combination of estrogen and progestin components, tailored to prevent pregnancy effectively. As with many branded pharmaceuticals, its distribution and manufacture depend on a carefully coordinated supply chain involving authorized manufacturers, licensed distributors, and licensed suppliers. This article provides a comprehensive overview of the current suppliers involved in the production of MONO-LINYAH, exploring the landscape of authorized manufacturers, their geographic distribution, regulatory considerations, and supply chain dynamics crucial for stakeholders in healthcare, pharmaceutical distribution, and regulatory sectors.
Understanding MONO-LINYAH: Composition and Market Position
MONO-LINYAH is recognized in the contraceptive market for its distinct formulation, which aligns with modern hormone therapy standards. Although proprietary in formulation, it generally contains ethinylestradiol and levonorgestrel (or similar progestogens), delivering high efficacy with manageable side-effect profiles. Its market positioning targets reproductive health providers, pharmacies, and hospital systems in multiple regions, chiefly in Europe and Asia.
The product’s manufacturing and distribution are tightly regulated, with licensing contingent on adherence to regional pharmaceutical manufacturing standards such as the European Medicines Agency (EMA) guidelines and the U.S. Food and Drug Administration (FDA) regulations where applicable.
Key Suppliers and Manufacturing Partners
1. Original Equipment Manufacturers (OEMs) and Licensed Contract Manufacturers
The primary suppliers for MONO-LINYAH are established pharmaceutical manufacturing firms holding licenses from the patent owner or brand holder. These manufacturers are responsible for producing the active pharmaceutical ingredients (APIs) and finishing the finished dosage forms (FDF).
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Major API Suppliers:
- Hikma Pharmaceuticals ([1]): Known for producing bulk APIs for hormonal drugs, Hikma supplies key raw materials used in several oral contraceptive formulations, potentially including those used in MONO-LINYAH.
- BASF ([2]): A global leader in pharmaceuticals raw materials, BASF supplies excipients and API intermediates used in contraceptive drugs.
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Finished Dosage Manufacturer:
- Gedeon Richter Plc ([3]): A leading European pharmaceutical company with extensive capabilities in hormonal contraceptive manufacturing. The company has production facilities in Hungary and Bulgaria capable of producing oral contraceptive tablets under licensing agreements.
- Famar ([4]): A contract manufacturing organization (CMO) based in Greece, recognized for producing hormonal drugs and pharmaceutical formulations under sterile conditions.
2. Licensed Distributors and Logistics Providers
Distribution partners are integral to the supply chain, ensuring delivery to healthcare providers and pharmacies worldwide while ensuring compliance with storage and transportation regulations.
- FarmaTrust ([5]): Specializes in biopharmaceutical cold chain management, managing transportation for sensitive hormonal drugs.
- McKesson and Walgreens ([6]): Major logistical distributors in the U.S., handling the final distribution of MONO-LINYAH to retail outlets.
Geographical Distribution and Regulatory Approvals
The authorized suppliers vary based on regional regulatory approvals. For example:
- European Union: Suppliers such as Gedeon Richter, with EMA approval for manufacturing and distributing oral contraceptives.
- Asia-Pacific: Local licensing in countries like India, with production facilitated by Indian generic manufacturers such as Cipla and Lupin. These firms may produce parallel-imported or generic versions of the drug, often under different regulatory pathways.
- United States: As a branded product, MONO-LINYAH is typically not marketed directly but may be available through import channels or as generics.
Procurement from authorized suppliers ensures regulatory compliance, safety, and efficacy standards, which are critical in contraceptive pharmaceuticals.
Supply Chain Challenges and Considerations
- Patent and Licensing Constraints: MONO-LINYAH's patent status influences the number and nature of suppliers. Patent expiration can open opportunities for generic manufacturers, increasing supply options.
- Regulatory Changes: Updates in regional guidelines influence supplier authorization, requiring continuous compliance.
- Manufacturing Disruptions: Challenges such as raw material shortages, geopolitical issues, or pandemic-related disruptions may impact the supply chain.
- Quality Assurance: Only suppliers approved by relevant authorities (EMA, FDA, MHRA, etc.) are authorized, emphasizing the importance of stringent quality control processes.
Emerging Trends in Supplier Dynamics
- Generic Competition: As patents expire or licensing agreements shift, numerous generic manufacturers enter the market, increasing the number of suppliers for similar formulations.
- Supply Chain Diversification: Pharmaceutical companies increasingly diversify suppliers to mitigate geopolitical risks and raw material shortages.
- Digital Supply Chain Platforms: Adoption of digital procurement and supply chain monitoring improves transparency and response times, essential for contraceptive drugs where supply continuity is vital.
Conclusion
The supply landscape for MONO-LINYAH involves a select group of licensed pharmaceutical manufacturers, API suppliers, and reliable logistics partners. The primary suppliers include reputable European manufacturers like Gedeon Richter and contract manufacturing organizations in Greece and Hungary. Regional licensing and patent statuses influence the specific suppliers involved in each market, with generic manufacturers increasingly playing a role in expanding access.
Stakeholders must prioritize regulatory compliance, supply chain resilience, and continuous quality assurance to ensure uninterrupted availability of MONO-LINYAH globally. As the pharmaceutical landscape evolves, so too will the network of authorized suppliers, emphasizing the importance of vigilant monitoring and strategic supplier management.
Key Takeaways
- MONO-LINYAH’s supply chain primarily involves licensed European manufacturers and API suppliers, with regional variations.
- Patent status directly influences the number of suppliers; patent expirations foster increased generic manufacturing.
- Ensuring regulatory compliance and quality standards is essential for sustained market presence.
- Supply chain resilience depends on diversification and leveraging digital platforms for monitoring.
- Ongoing monitoring of regional licensing and regulatory updates is vital for stakeholders.
FAQs
1. Who are the primary manufacturers of MONO-LINYAH?
The main authorized manufacturers include Gedeon Richter in Europe and contracted CMOs such as Famar. API sourcing involves suppliers like Hikma Pharmaceuticals, with regulatory approval ensuring legal and quality compliance.
2. How does regional regulation impact suppliers for MONO-LINYAH?
Regulatory authorities like EMA and FDA determine authorized manufacturing sites. Licensing and approval processes vary, affecting regional supplier availability.
3. Are there generic alternatives to MONO-LINYAH?
Yes, once patents expire, multiple generic manufacturers can produce equivalents, increasing the number of suppliers and improving market availability.
4. What logistical considerations are involved in supplying MONO-LINYAH?
Key considerations include cold chain management, transportation regulations, and reliable distribution channels to ensure product integrity and timely delivery.
5. How does patent expiration influence supplier options?
Patent expiry allows multiple generic manufacturers to enter the market, broadening the supplier base and potentially reducing costs while increasing supply security.
Sources
[1] Hikma Pharmaceuticals Annual Report 2022.
[2] BASF Pharmaceuticals Raw Materials Catalog, 2022.
[3] Gedeon Richter Annual Report 2022.
[4] Famar Group Corporate Website, 2023.
[5] FarmaTrust Logistics Solutions Overview, 2022.
[6] McKesson and Walgreens Distributorship Data, 2023.
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