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Suppliers and packagers for generic pharmaceutical drug: norethindrone acetate
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norethindrone acetate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | NORETHINDRONE ACETATE | norethindrone acetate | TABLET;ORAL | 200275 | ANDA | AvKARE | 42291-650-90 | 90 TABLET in 1 BOTTLE (42291-650-90) | 2013-06-18 |
| Amneal Pharms | NORETHINDRONE ACETATE | norethindrone acetate | TABLET;ORAL | 200275 | ANDA | Amneal Pharmaceuticals LLC | 65162-475-03 | 30 TABLET in 1 BOTTLE (65162-475-03) | 2009-07-01 |
| Amneal Pharms | NORETHINDRONE ACETATE | norethindrone acetate | TABLET;ORAL | 200275 | ANDA | Amneal Pharmaceuticals LLC | 65162-475-05 | 50 TABLET in 1 BOTTLE (65162-475-05) | 2009-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Norethindrone Acetate
Introduction
Norethindrone acetate, a synthetic progestin primarily used in hormonal contraceptives and hormone replacement therapy, plays a pivotal role in reproductive health management globally. The demand for norethindrone acetate is driven by its extensive applications in oral contraceptives, menopausal therapy, and other hormonal treatments. As a result, a robust supply chain comprising chemistry manufacturers, bulk drug producers, and authorized distributors is essential to meet global healthcare needs. This article provides an authoritative overview of key suppliers specializing in norethindrone acetate, highlighting their manufacturing capacities, regulatory compliance, and strategic positioning within the global pharmaceutical landscape.
Global Market Landscape and Supplier Overview
The manufacturing of norethindrone acetate is concentrated among a select group of pharmaceutical and chemical companies, predominantly in Asia, Europe, and North America. These suppliers are distinguished by their capacity for large-scale production, adherence to stringent quality standards, and active engagement with regulatory agencies such as the FDA, EMA, and WHO.
Major Suppliers of Norethindrone Acetate
1. HLL Lifecare Limited (India)
HLL Lifecare is a leading Indian government enterprise with a diversified portfolio, including hormonal active pharmaceutical ingredients (APIs). The company has established itself as a significant supplier of norethindrone acetate, catering both to domestic demands and export markets.[1] HLL emphasizes compliance with international quality standards, including WHO-GMP certification, and offers competitive pricing due to its strategic location and manufacturing scale.
2. Winthrop Chemicals (India)
Winthrop Chemicals has developed a reputation for producing high-quality hormone APIs, including norethindrone acetate. Their site operates under strict GMP protocols, and they are recognized for their rigorous quality control measures. Winthrop’s capacity supports large-volume orders for generic and branded pharmaceutical manufacturers globally.[2]
3. Jiangsu Hengrui Medicine Co., Ltd. (China)
As one of China's leading pharmaceutical APIs producers, Jiangsu Hengrui offers norethindrone acetate as part of its hormonal API portfolio. The company invests heavily in R&D and manufacturing automation, ensuring high purity and consistency. Their strategic focus includes expanding export agreements within North America and Europe.[3]
4. Mylan (now part of Viatris)
Viatris, through its predecessor Mylan, supplies a broad range of hormonal APIs, including norethindrone acetate, to global markets. The company's extensive distribution network, combined with its robust manufacturing facilities in the U.S. and India, supports reliable procurement and supply chain stability.[4]
5. Teva Pharmaceutical Industries Ltd.
Teva’s API division supplies norethindrone acetate, leveraging its global manufacturing footprint. With multiple facilities compliant with cGMP standards, Teva emphasizes product purity, stability, and regulatory compliance, making it a favored supplier among branded and generic drug companies.[5]
6. Dr. Reddy’s Laboratories (India)
Dr. Reddy’s offers a range of hormonal APIs, including norethindrone acetate, supported by its strong R&D pipeline and manufacturing expertise. The company has achieved multiple certifications for quality and sustainability standards, enabling entry into regulated markets worldwide.[6]
Emerging Suppliers and Regional Players
Besides these major players, several regional suppliers and emerging manufacturers are entering the market, often providing competitive pricing and flexible supply options. These include companies in countries such as South Korea, Vietnam, and Brazil, which are rapidly expanding their API production capabilities in response to global demand shifts.
Factors Influencing Supplier Selection
When sourcing norethindrone acetate, pharmaceutical companies prioritize several critical factors:
- Regulatory Compliance: Suppliers with WHO-GMP, US FDA, EMA, or other relevant certifications ensure adherence to quality standards necessary for global markets.
- Manufacturing Capacity: Large-scale production capability mitigates supply disruptions, especially important amid pandemic-related logistic challenges.
- Price and Supply Chain Reliability: Competitive pricing coupled with robust logistics and distribution networks influences procurement decisions.
- Quality Assurance: High purity, consistent batch-to-batch quality, and comprehensive analytical documentation are essential.
- Strategic Geographic Location: Proximity to key markets can reduce lead times and transportation costs.
Regulatory and Quality Considerations
Suppliers adhering to internationally recognized quality standards streamline approval processes in highly regulated markets. Many top-tier manufacturers maintain certifications like WHO-GMP, ISO 9001, and other regional quality standards, facilitating quicker entry into markets such as North America, Europe, and Asia.
Trends and Future Outlook
The global demand for norethindrone acetate is projected to grow, driven by expanding contraceptive and reproductive health markets. Suppliers are investing in manufacturing automation, quality control, and international certifications to remain competitive. Additionally, the rise of biosimilar and generic hormone products highlights ongoing opportunities for API suppliers to expand capacities and diversify product portfolios.
Key Challenges for Suppliers
- Regulatory hurdles in different jurisdictions require comprehensive documentation and compliance.
- Price competition, particularly from emerging markets, pressures established suppliers to optimize costs.
- Supply chain disruptions caused by geopolitical tensions, pandemics, and logistical bottlenecks necessitate strategic planning and diversified production sites.
Conclusion
The procurement of norethindrone acetate hinges on identifying suppliers with proven quality, reliable capacity, and compliant manufacturing practices. Top-tier companies such as HLL Lifecare, Winthrop Chemicals, Jiangsu Hengrui, and Teva remain major players, but emerging manufacturers and regional suppliers are increasingly influential. Moving forward, strategic partnerships with reputable suppliers that meet global regulatory standards will be critical for pharmaceutical companies seeking consistent and compliant supply chains.
Key Takeaways
- Global supply chain leaders for norethindrone acetate include HLL Lifecare, Winthrop Chemicals, Jiangsu Hengrui, Teva, and Dr. Reddy’s.
- Quality compliance with WHO-GMP, FDA, and EMA standards significantly influences supplier selection.
- Manufacturing capacity and supply reliability are critical, especially in the context of global logistical challenges.
- Strategic regional presence can reduce lead times and costs for international procurement.
- Emerging suppliers in Asia and Latin America are expanding, offering competitive pricing options.
FAQs
1. What are the primary regions supplying norethindrone acetate?
Asia (India, China, South Korea), Europe (mainly through companies like Teva), and North America (by companies such as Viatris) are the primary regions supplying norethindrone acetate, with emerging players in Latin America and Southeast Asia.
2. How do quality standards impact supplier selection for norethindrone acetate?
Strict adherence to WHO-GMP, FDA, and EMA standards ensures product safety, efficacy, and regulatory acceptance, making such suppliers more desirable for global pharmaceutical companies.
3. Are there regional differences in pricing for norethindrone acetate?
Yes, manufacturing costs, regulatory compliance expenses, and logistical factors contribute to regional variations, with Asian suppliers often offering more competitive prices.
4. How important is supply chain diversification in sourcing norethindrone acetate?
Highly important, as it reduces dependency on a single supplier or region, mitigating risks associated with geopolitical tensions, pandemics, or logistical disruptions.
5. What future developments could affect the supply landscape?
Expanding global markets, technological innovations in manufacturing, regulatory changes, and increased demand for hormonal therapies will influence supplier capacities and competition dynamics.
References
[1] HLL Lifecare Limited, Official Website.
[2] Winthrop Chemicals, Company Profile.
[3] Jiangsu Hengrui Medicine Co., Ltd, Corporate Overview.
[4] Viatris, Product Portfolio.
[5] Teva Pharmaceutical Industries Ltd., API Division.
[6] Dr. Reddy’s Laboratories, R&D and Manufacturing Capabilities.
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