Suppliers and packagers for generic pharmaceutical drug: norgestrel

norgestrel

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-01	1 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK	2024-03-04
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-03	3 BLISTER PACK in 1 CARTON (0113-8101-03) / 28 TABLET in 1 BLISTER PACK	2024-03-04
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-04	4 BLISTER PACK in 1 PACKAGE (0113-8101-04) / 28 TABLET in 1 BLISTER PACK	2024-03-04
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-06	6 BLISTER PACK in 1 CARTON (0113-8101-06) / 28 TABLET in 1 BLISTER PACK	2024-03-04

Suppliers for the Pharmaceutical Drug Norgestrel: A Comprehensive Analysis of Global Manufacturing and Market Dynamics

Norgestrel, a synthetic progestin integral to hormonal contraceptives and neuroprotective therapies, has seen evolving demand and regulatory shifts in recent years. This report examines the global supplier landscape for norgestrel, analyzing key manufacturers, regulatory developments, market trends, and challenges. With the U.S. Food and Drug Administration (FDA) approving its over-the-counter availability in 2023[9][11], the drug’s supply chain has expanded, driven by partnerships between pharmaceutical giants and emerging manufacturers. Below, we explore the geopolitical distribution of suppliers, quality certifications, and innovations shaping this critical sector.

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Pharmaceutical and Regulatory Context of Norgestrel

Chemical Profile and Therapeutic Applications

Norgestrel is a racemic mixture of two enantiomers, with the levorotatory form (levonorgestrel) being biologically active[2]. It functions primarily as a progestin in oral contraceptives, inhibiting ovulation and altering cervical mucus to prevent fertilization[5][9]. Beyond reproductive health, research highlights its antioxidant properties, particularly in mitigating light-induced oxidative stress in retinal cells[1]. This dual therapeutic role underscores its importance in both mainstream and niche pharmaceutical markets.

Regulatory Milestones and Over-the-Counter Transition

The FDA’s July 2023 approval of norgestrel for nonprescription use marked a pivotal shift in accessibility[9][11]. Perrigo Company plc, via its subsidiary HRA Pharma, now markets the drug under the brand name Opill, with availability slated for 2024[11]. This transition required rigorous safety evaluations, including assessments of self-diagnosis accuracy and adherence to dosing protocols[11]. Regulatory bodies like the European Medicines Agency (EMA) and World Health Organization (WHO) have long recognized norgestrel’s efficacy, listing it among essential medicines for global health systems[7].

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Global Supplier Landscape

Key Manufacturers and Their Certifications

The production of norgestrel is concentrated among multinational corporations and specialized API manufacturers. Prominent suppliers include:

• Gonane Pharma (India): A WHO-GMP-certified producer with over 25 years of experience, supplying high-purity norgestrel to regulated markets[2][10].
• Gedeon Richter (Hungary): A European leader in hormonal APIs, compliant with EU-GMP and FDA standards[2][4].
• Bayer (Germany): Historically significant in contraceptive development, Bayer leverages its infrastructure for large-scale norgestrel synthesis[2][10].
• Lupin (India): Specializes in cost-effective generic APIs, targeting emerging markets in Asia and Africa[2][10].

Emerging players like Shandong Octagon Chemicals (China) and Aurora Industry Co., Ltd. (China) have entered the market, offering competitive pricing but facing scrutiny over quality consistency[4][12]. Certifications such as ISO 9001, USP, and CEP (Certification of Suitability to the European Pharmacopoeia) are critical differentiators[2][10].

Regional Production Hubs

• Asia-Pacific: Dominated by Indian and Chinese manufacturers, this region accounts for ~60% of global API production due to lower labor costs and streamlined regulatory processes[2][4][12]. For instance, Manus Aktteva Biopharma (India) provides norgestrel intermediates with full technical documentation[13][18].
• Europe: Hungary’s Gedeon Richter and Germany’s Bayer maintain stringent quality controls, catering primarily to U.S. and EU markets[2][10].
• North America: While no major norgestrel API producers exist, distributors like LGM Pharma and MedicaPharma facilitate regional access through partnerships with overseas manufacturers[16][18].

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Manufacturing Processes and Quality Assurance

Synthesis and Intermediate Sourcing

Norgestrel synthesis typically involves steroid nucleus modification from plant-derived precursors like diosgenin. Suppliers such as Xi’an Biohorlden (China) and Wuhan Senwayer Century Chemical optimize this process using microwave-assisted reactions to enhance yield[8][12]. Critical intermediates, including 13-ethyl-17α-hydroxy-18,19-dinorpregn-4-en-20-yn-3-one, require precise stereochemical control to ensure enantiomeric purity[5][16].

Quality Control Measures

Adherence to Good Manufacturing Practices (GMP) is non-negotiable. Gonane Pharma subjects batches to high-performance liquid chromatography (HPLC) and mass spectrometry to verify purity >99.5%[2][10]. Stability testing under ICH guidelines (e.g., Q1A) ensures shelf-life compliance across climatic zones[18]. Suppliers targeting the U.S. must file Drug Master Files (DMFs) with the FDA, detailing synthesis pathways and impurity profiles[16][17].

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Market Trends and Competitive Dynamics

Demand Drivers and Pricing Strategies

Global contraceptive prevalence rates exceeding 60% have bolstered norgestrel demand, particularly in low-income regions[7]. However, pricing remains volatile. TargetMol Chemicals offers norgestrel at $1,520–$2,500 per 25–100 mg for research use, while bulk pharmaceutical-grade API costs ~$0.1–$100/kg[5][8]. Indian suppliers like Lupin leverage economies of scale to undercut competitors by 15–20%[2][10].

Digital B2B Platforms and Supply Chain Innovation

Marketplaces like Pharmaoffer and Pipelinepharma streamline supplier-buyer interactions, enabling real-time price comparisons and audit report access[2][7]. These platforms mitigate risks of counterfeit APIs—a persistent issue in unregulated markets—by vetting suppliers for GMP compliance[7][10].

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Challenges in the Norgestrel Supply Chain

Regulatory and Environmental Hurdles

California’s Proposition 65 mandates cancer risk warnings for norgestrel products, complicating packaging and marketing in the U.S.[1]. Environmental regulations in the EU and China increasingly penalize steroid manufacturers for solvent waste, pushing firms like Bayer to adopt green chemistry principles[4][10].

Raw Material Sourcing and Geopolitical Risks

Dependence on Chinese intermediates—60% of global supply—exposes the sector to trade restrictions[12]. The U.S.-China trade war has prompted dual sourcing strategies, with MedicaPharma stockpiling key reagents in Dutch warehouses[18].

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Future Outlook and Strategic Recommendations

Expansion of OTC Markets and Female-Centric Distribution

The OTC approval of Opill opens avenues for retail pharmacy partnerships and telehealth platforms[11]. Suppliers should invest in patient education materials to ensure safe self-administration, potentially reducing unintended pregnancies by 30%[11].

Sustainable Manufacturing Initiatives

Leading suppliers are adopting enzymatic catalysis and continuous flow reactors to minimize waste. Gedeon Richter’s pilot plant in Budapest has reduced solvent use by 40% through solvent recycling[4][10].

Strategic Partnerships for Market Penetration

Collaborations between API manufacturers and generic drugmakers, such as Cipla’s alliance with Symbiotec Pharmalab, enable rapid entry into African and Southeast Asian markets[16][17].

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Key Takeaways

1. Diverse Supplier Base: Over 20 certified manufacturers across India, China, and Europe ensure robust norgestrel supply, though quality variances persist.
2. Regulatory Shifts: FDA’s OTC approval and Proposition 65 warnings necessitate adaptive packaging and labeling strategies.
3. Innovation in Synthesis: Green chemistry and digital B2B platforms are reshaping production and distribution.
4. Emerging Markets: Africa and Southeast Asia present growth opportunities, contingent on affordable pricing and regulatory harmonization.

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FAQs

1. Which countries are the largest norgestrel suppliers?
   India and China dominate API production, while Hungary and Germany lead in high-purity exports[2][4][12].

2. How does OTC approval impact suppliers?
   Manufacturers must scale production and partner with distributors to meet retail demand, ensuring consistent quality[9][11].

3. What certifications are critical for norgestrel suppliers?
   WHO-GMP, FDA-DMF, and CEP certifications are essential for regulated market access[2][10][16].

4. How do digital platforms enhance supplier reliability?
   Platforms like Pharmaoffer verify GMP compliance and provide audit reports, reducing counterfeit risks[2][7].

5. What are the environmental challenges in norgestrel manufacturing?
   Solvent waste management and adherence to green chemistry principles are critical for regulatory compliance[4][10].

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This report synthesizes data from regulatory filings, supplier databases, and market analyses to provide a panoramic view of the norgestrel supply chain. As demand grows, stakeholders must balance cost-efficiency with quality and sustainability to thrive in this dynamic sector.

References

1. https://www.adooq.com/norgestrel.html
2. https://pharmaoffer.com/api-excipient-supplier/contraceptives/norgestrel
3. https://www.manusaktteva.com/api/Levonorgestrel
4. https://pharmaoffer.com/api-excipient-supplier/progestagens/levonorgestrel
5. https://www.targetmol.com/compound/(+)-norgestrel
6. https://www.biomol.com/products/chemicals/lipids/norgestrel-d6-cay28477-1
7. https://www.pipelinepharma.com/levonorgestrel-manufacturers
8. https://www.echemi.com/supplier/pid_Rock12084-norgestrel.html
9. https://en.wikipedia.org/wiki/Norgestrel
10. https://pharmaoffer.com/api-excipient-supplier/contraceptives/norgestrel/gmp
11. https://medauth2.mdedge.com/content/norgestrel-nonprescription-contraception-what-you-and-your-patients-need-know
12. https://www.made-in-china.com/manufacturers/norgestrel.html
13. https://www.si.edu/object/chinese-compound-norgestrel-oral-contraceptives-beijing-pharmaceutical-factory:nmah_1141987
14. https://www.manusaktteva.com/api/Norgestrel
15. https://nowpatient.com/medications/norgestrel
16. https://www.pharmacompass.com/manufacturers-suppliers-exporters/norgestrel
17. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/norgestrel
18. https://www.medicapharma.com/shop/hormones/norgestrel/

Last updated: 2025-04-19