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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Branded Pharm	NOR-QD	norethindrone	TABLET;ORAL-28	017060	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals, Inc.	0480-3475-16	6 PACKAGE in 1 CARTON (0480-3475-16) / 28 TABLET in 1 PACKAGE	2023-12-01
Teva Branded Pharm	NOR-QD	norethindrone	TABLET;ORAL-28	017060	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	52544-629-28	6 PACKAGE in 1 CARTON (52544-629-28) / 28 TABLET in 1 PACKAGE	2005-05-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

NOR-QD is a well-established medication used primarily for the management of menopausal symptoms, including hot flashes, and certain menstrual disorders. The drug typically contains norethindrone, a synthetic progestin, and is marketed under various brand names. The procurement of NOR-QD relies heavily on the supply chain ecosystem, which involves multiple suppliers for active pharmaceutical ingredients (APIs), excipients, manufacturing, and packaging. Understanding these suppliers, their geographical distribution, and regulatory compliance is crucial for stakeholders aiming to ensure steady supply, quality, and regulatory adherence.

Understanding NOR-QD Composition and Manufacturing

NOR-QD, commonly known as a norethindrone-based contraceptive or hormone replacement therapy (HRT) agent, is formulated with active ingredients that require meticulous raw material sourcing and manufacturing processes. The critical components include:

Active Pharmaceutical Ingredient (API): Norethindrone
Excipients: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, etc.

The quality and availability of the API are paramount, often dictating the drug's manufacturing volume and supply stability.

Key Suppliers of NOR-QD API (Norethindrone)

Major API Manufacturers

The scarcity or continuity of NOR-QD hinges on suppliers of norethindrone, which can originate from various regions, including India, China, and Europe. The primary API manufacturers include:

KSS Bio-Pharma (India): A leading API supplier, KSS Bio-Pharma specializes in progestins, including norethindrone. They hold multiple certifications (GMP, ISO 9001) and supply to global pharmaceutical companies. Their production facilities are compliant with USFDA and EU standards, ensuring high-quality standards.
Hovione (Portugal): Known for custom synthesis and APIs, Hovione produces norethindrone for various clients, with a focus on high purity and regulatory compliance.
Lupin Limited (India): A global pharmaceutical giant, Lupin manufactures APIs for hormonal drugs, including norethindrone. Their extensive API manufacturing facilities are a key supply source for generics and branded medicines.
Jiangsu Hengrui Medicine Co., Ltd. (China): A prominent Chinese API producer, Hengrui supplies hormones and progestin APIs globally, including norethindrone.

Emerging API Suppliers

New entrants from India and China are increasingly gaining approval and market share owing to cost competitiveness and expanding manufacturing capabilities:

Sun Pharmaceutical Industries Ltd. (India): Evolving as a key API supplier for hormones, including norethindrone.
Zhejiang Hisun Pharmaceutical Co., Ltd. (China): Expanding production of hormonal APIs for export markets.

Regulatory and Quality Considerations

Suppliers must adhere to Good Manufacturing Practices (GMP) and hold appropriate certifications such as USFDA, EMA, or PMDA approvals. These certifications assure quality and safety compliance, crucial for API approval and subsequent drug manufacturing.

Excipients and Other Raw Material Suppliers

Apart from APIs, NOR-QD formulations depend on high-quality excipients sourced from specialized suppliers:

Dow Chemical, FMC Corporation, and Lipoid supply pharmaceutical-grade excipients (lactose, microcrystalline cellulose, starches).
These ingredients should meet pharmacopeial standards, including USP, EP, and JP, to maintain formulation integrity.

Contract Manufacturing and Brand Suppliers

Some pharmaceutical companies outsource final formulation, packaging, or distribution:

Contract Manufacturing Organizations (CMOs): Companies like Catalent, Recipharm, and Baxter provide formulation and packaging services, ensuring scalability and quality robustness.
Brand Distributors: Large pharmaceutical firms such as Pfizer, Teva, and Mylan manufacture NOR-QD under licensing agreements, occasionally sourcing APIs from multiple suppliers to reduce supply chain risks.

Regional Dynamics and Supply Chain Challenges

The global supply chain for NOR-QD faces several challenges:

Regulatory Hurdles: Certifications, inspections, and compliance standards vary across regions, affecting supplier eligibility.
Geopolitical Risks: Political tensions and trade disputes, especially between the US and China, can disrupt supply chains.
Raw Material Cost Fluctuations: Changes in raw material prices impact the supplier landscape, incentivizing diversification.
Manufacturing Capacity Constraints: Capacity limits at major API plants may influence supply continuity, especially during pandemic-related disruptions.

Strategic Supplier Selection

For pharmaceutical companies aiming to mitigate risks and ensure consistent supply of NOR-QD, strategic sourcing involves:

Diversifying supplier base across regions to avoid overreliance.
Prioritizing suppliers with strong regulatory track records and certifications.
Engaging in long-term contracts with reliable API producers to secure capacity.
Monitoring geopolitical developments that could influence supply chains.

Regulatory Landscape and Compliance

Suppliers must maintain compliance with international standards, including:

US FDA regulations for suppliers serving North American markets.
EMA guidelines for European distribution.
WHO prequalification for supply to developing nations.

Failure to meet these standards can result in supply disruptions or regulatory sanctions.

Conclusion

The supply ecosystem for NOR-QD involves a complex web of API producers, excipient providers, contract manufacturers, and distributors, primarily located in India, China, and Europe. Ensuring a reliable and high-quality supply requires robust supplier qualification, diversification strategies, and strict adherence to regulatory standards. As global markets evolve and supply chain challenges persist, stakeholders must prioritize transparency, regulatory compliance, and contingency planning.

Key Takeaways

Dominant API suppliers for NOR-QD are based in India (Lupin, Sun Pharma), China (Hengrui, Zhejiang Hisun), and Europe (Hovione).
Supplier qualification, regulatory compliance, and diversified sourcing are essential to mitigate supply risks.
Excipients and manufacturing services are sourced globally, with key providers maintaining high standards.
Supply chain resilience depends on regional geopolitical stability, capacity management, and compliance with regulatory standards.
Strategic partnerships and long-term sourcing agreements can safeguard supply continuity.

FAQs

1. Who are the leading API manufacturers for NOR-QD?
Lupin Limited (India), Hovione (Portugal), Jiangsu Hengrui Medicine (China), and KSS Bio-Pharma (India) are among the primary API producers for norethindrone, the active ingredient in NOR-QD.

2. What regulatory certifications should suppliers of NOR-QD APIs possess?
Suppliers should hold certifications such as USFDA approval, European EMA GMP compliance, or WHO prequalification, ensuring adherence to strict quality and safety standards.

3. How can pharmaceutical companies mitigate supply chain risks for NOR-QD?
Diversifying supplier sources across regions, establishing long-term contracts, monitoring geopolitical developments, and maintaining strategic inventory reserves are effective risk mitigation strategies.

4. Are there regional differences affecting the procurement of NOR-QD ingredients?
Yes. Differences in regulatory requirements, manufacturing standards, and geopolitical stability influence supplier eligibility and supply continuity across regions.

5. What challenges currently impact the supply chain of NOR-QD?
Disruptions include regulatory delays, capacity constraints, geopolitical tensions, raw material price fluctuations, and COVID-19-related manufacturing interruptions.

Sources:
[1] Pharmaceutical industry reports on hormone API manufacturing, 2022.
[2] US FDA and EMA GMP compliance guidelines.
[3] Market analysis of hormonal API suppliers, 2023.

Suppliers and packagers for nor-qd

nor-qd

Suppliers for the Pharmaceutical Drug: NOR-QD