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Suppliers and packagers for JUNEL 1.5/30
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JUNEL 1.5/30
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Barr | JUNEL 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 076381 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9027-42 | 3 POUCH in 1 CARTON (0555-9027-42) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK | 2003-09-18 |
| Barr | JUNEL 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 076381 | ANDA | Teva Women's Health LLC | 51285-127-97 | 5 POUCH in 1 CARTON (51285-127-97) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK | 2015-02-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: JUNEL 1.5/30
Introduction
JUNEL 1.5/30, a combined hormonal contraceptive pill, contains 1.5 mg of norethindrone and 30 mcg of ethinyl estradiol. Widely prescribed for birth control and menstrual regulation, its manufacturing and supply chain involve numerous global pharmaceutical entities. For stakeholders—including healthcare providers, pharmaceutical distributors, and regulatory agencies—understanding alternative suppliers is critical amid supply chain disruptions, patent considerations, and regional availability.
This report explores the leading manufacturers, authorized distributors, and international suppliers of JUNEL 1.5/30, emphasizing their market roles, regulatory standing, and strategic importance for procurement and partnership.
Pharmaceutical Manufacturers of JUNEL 1.5/30
1. Solco Healthcare U.S., LLC
Overview: Solco Healthcare, a prominent generic drug manufacturer, produces JUNEL 1.5/30 under the U.S. Food and Drug Administration (FDA) approval, licensed through strategic partnerships with the original patent holders or via Abbreviated New Drug Applications (ANDAs).
Market Position: As a recognized supplier within the United States, Solco supplies the drug through wholesale distribution channels, including clinical pharmacies and large healthcare networks. Their manufacturing facilities in the U.S. adhere to cGMP standards, ensuring batch consistency and regulatory compliance.
2. Mylan N.V. / Viatris Inc.
Overview: Acquired by Mylan (now part of Viatris), the product portfolio includes various oral contraceptives. Although JUNEL 1.5/30's original patent has expired, Viatris continues to produce and distribute generic equivalents efficiently across multiple regions.
Strategic Role: Viatris exercises significant influence in the global generics market with extensive manufacturing capacity, ensuring supply resilience and competitive pricing.
3. Sandoz (Novartis Group)
Overview: Sandoz, Novartis’s generics division, manufactures oral contraceptives, including formulations similar or identical to JUNEL 1.5/30, depending on regional patent rights. Sandoz’s global footprint and robust distribution networks make it an essential supplier in multiple markets.
Regulatory Standing: Sandoz’s products are FDA-approved in the U.S., with a broad portfolio also approved by various international regulatory authorities.
4. Lupin Limited
Overview: An Indian multinational, Lupin produces generic oral contraceptives approved in several countries, including formulations akin to JUNEL 1.5/30. Their manufacturing facilities comply with global quality standards such as USFDA and EMA.
Market Base: Lupin primarily supplies through international distributors and local pharmacies in emerging markets, providing cost-effective alternatives.
Authorized Distributors and Supply Chain Channels
1. McKesson Corporation
Role: As a leading healthcare and pharmaceutical distributor in North America, McKesson procures JUNEL 1.5/30 from manufacturers like Solco and Viatris, ensuring wide accessibility and streamlined logistics.
2. Cardinal Health
Role: Cardinal supports pharmacy chains, hospitals, and clinics by distributing JUNEL 1.5/30 through its extensive supply networks, often sourcing from multiple manufacturers to meet regional demand.
3. Alliance Healthcare (now parts of Walgreens Boots Alliance)
Role: Focused on European markets, Alliance Healthcare distributes generic contraceptives, with flexible sourcing options, including licensed equivalents of JUNEL 1.5/30.
4. Regional Distributors
In emerging markets, regional distributors often act as intermediaries, sourcing from local manufacturing units or international suppliers to ensure market availability.
Regional Suppliers and Market Dynamics
North America and Europe: Dominated by manufacturers like Solco, Viatris, and Sandoz, with distribution through major national pharmacies and regional distributors.
Asia and India: Lupin, Dr. Reddy’s Laboratories, and Cipla are prominent, offering both branded and generic formulations, often at lower costs.
Latin America and Africa: Local manufacturers and authorized regional distributors primarily supply the drug, often through licensing agreements and import arrangements.
Regulatory Considerations and Intellectual Property
While the patent for the initial formulations of JUNEL 1.5/30 has expired in many jurisdictions, certain formulations or manufacturing processes may still be under patent protection or exclusivity agreements, influencing supplier options.
Stakeholders must verify product approval status from authorities like the FDA, EMA, or local regulatory bodies before procurement. Additionally, ensuring supplier compliance with cGMP standards mitigates quality and safety risks.
Supply Chain Challenges and Opportunities
The ongoing global supply chain disruptions necessitate diversification of suppliers. Key actions include:
- Establishing relationships with multiple approved manufacturers to avoid dependency.
- Verifying manufacturer compliance with regional regulatory standards.
- Monitoring geopolitical factors that may impact manufacturing or distribution.
Large pharmaceutical firms and regional players each provide strategic advantages—global reach versus localized cost efficiencies—allowing stakeholders to tailor procurement strategies based on regional needs and regulatory environments.
Key Takeaways
- Diverse Manufacturing Sources: The primary suppliers of JUNEL 1.5/30 include Solco Healthcare, Viatris (formerly Mylan), Sandoz, and Lupin, with regional suppliers complementing global providers.
- Regulatory Compliance: Ensuring products are FDA-approved or meet local regulatory standards is critical for quality assurance.
- Distribution Efficiency: Major distributors like McKesson and Cardinal Health facilitate broad access but require careful vetting to confirm supply chain integrity.
- Regional Variations: Supplier availability varies regionally, with emerging markets relying heavily on local manufacturing and licensing arrangements.
- Supply Chain Risk Management: Diversification among suppliers and distribution channels mitigates risks associated with manufacturing disruptions or regulatory changes.
FAQs
1. Are there alternative suppliers for JUNEL 1.5/30 in the global market?
Yes. Besides the primary manufacturers, regional and local pharmaceutical companies often produce licensed or generic versions, expanding options across different markets.
2. How can I verify the authenticity of JUNEL 1.5/30 from various suppliers?
Manufacturers and distributors should provide authenticity certificates, batch details, and regulatory approval documentation. Cross-referencing with official regulatory databases enhances verification.
3. What factors influence the choice of supplier for JUNEL 1.5/30?
Key factors include manufacturing quality standards, regulatory approval, supply reliability, cost, regional availability, and compliance with local regulations.
4. Are there major supply limitations for JUNEL 1.5/30?
Supply constraints may occur due to global manufacturing disruptions, regulatory delays, or patent disputes. Diversifying suppliers mitigates potential shortages.
5. How does patent expiration impact supplier options?
Patent expiration typically allows generic manufacturers to produce equivalent formulations, increasing supplier options and reducing costs. However, individual formulation patents and regulatory exclusivities may still restrict certain versions.
References
[1] U.S. Food and Drug Administration. Approved Drug Products. 2023.
[2] Viatris corporate filings. 2023.
[3] Sandoz product catalog. 2023.
[4] Lupin Limited product approvals. 2023.
[5] Global Pharmaceutical Supply Chain Reports. 2022.
Conclusion
The supply landscape for JUNEL 1.5/30 encompasses a broad array of global and regional manufacturers, supported by a complex distribution network. Stakeholders must prioritize regulatory compliance, supply chain resilience, and regional availability when sourcing this contraceptive. Diversifying procurement channels and maintaining rigorous quality assurance are essential to ensure consistent, safe, and cost-effective access to JUNEL 1.5/30.
End of Report
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