Suppliers and packagers for LOW-OGESTREL-21

LOW-OGESTREL-21

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dr Reddys Labs Sa	LOW-OGESTREL-21	ethinyl estradiol; norgestrel	TABLET;ORAL-21	075288	ANDA	Mayne Pharma Inc.	51862-564-06	6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01)	2016-08-03

Suppliers for the Pharmaceutical Drug: LOW-OGESTREL-21

Last updated: August 2, 2025

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Overview of LOW-OGESTREL-21

LOW-OGESTREL-21 is a generic oral contraceptive containing norgestrel, a synthetic progestogen, typically used for contraception. The formulation usually comprises 21 active hormone pills followed by 7 placebo pills, following a conventional 28-day cycle. As a widely prescribed contraceptive, LOW-OGESTREL-21 is produced and distributed globally, with numerous suppliers and manufacturers competing in this market.

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Market Landscape and Key Suppliers

The supply chain for LOW-OGESTREL-21 is characterized by several key players, ranging from major pharmaceutical manufacturers to contract manufacturing organizations (CMOs). The suppliers can be classified into the following categories:

• Branded and Generic Pharmaceutical Manufacturers
• Contract Manufacturing Organizations (CMOs)
• Active Pharmaceutical Ingredient (API) Suppliers

1. Major Pharmaceutical Companies Producing LOW-OGESTREL-21

While LOW-OGESTREL-21 is a generic formulation, its active ingredients and finished dosage forms are primarily supplied by established pharmaceutical firms with extensive manufacturing and distribution networks.

a. Bayer AG
Bayer is a leading global pharmaceutical company that produces various oral contraceptives, including formulations similar to LOW-OGESTREL-21. While Bayer's original OGESTREL brand was replaced by generics, Bayer’s extensive API facilities and contractual relationships often supply formulations worldwide.

b. Teva Pharmaceutical Industries Ltd.
Teva is one of the largest generic pharmaceutical manufacturers globally. They produce and supply various oral contraceptives, including norgestrel-based formulations, and often act as a sourcing partner for lower-cost generics.

c. Mylan/Microsoft
Now part of Viatris, Mylan has historically been a significant supplier of oral contraceptives, including norgestrel formulations. Their broad manufacturing capabilities enable them to produce LOW-OGESTREL-21-like products for various markets.

d. Sandoz (Novartis)
Sandoz is a prominent producer of generics, including contraceptive pills. They supply both branded and unbranded contraceptive formulations. Their global footprint and proven manufacturing standards make them a reliable supplier.

e. Gedeon Richter
A major European pharmaceutical player, Richter manufactures various hormonal contraceptives, including norgestrel-based pills, often serving European and emerging markets.

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2. Contract Manufacturing Organizations (CMOs)

In many cases, pharmaceutical companies outsource manufacturing of LOW-OGESTREL-21 to CMOs to optimize costs and manufacturing capacity.

a. Patheon (Thermo Fisher Scientific)
Patheon, a global CMO, offers development and manufacturing services for oral solid dose formulations, including hormonal contraceptives.

b. Almac Group
Almac provides pharmaceutical development and manufacturing services for oral contraceptive tablets, with expertise in hormone-based products.

c. Zhejiang Hisun Pharmaceutical Co., Ltd.
A China-based CMO with capabilities in oral solid dose manufacturing, including hormonal products supplied to global markets.

d. Zhejiang Huahai Pharmaceutical Co., Ltd.
Specializes in active pharmaceutical ingredients and finished dosage forms, including contraceptive tablets supplied internationally.

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3. API Suppliers for Norgestrel

The active drug ingredient in LOW-OGESTREL-21 is norgestrel, a synthetic steroid. The supply of high-quality norgestrel API is crucial for processing and formulation.

a. Zhejiang Sanyou Biological Technology Co., Ltd.
A significant producer of steroidal APIs, including norgestrel, serving global markets.

b. Miteni S.p.A.
An Italian-based supplier of steroid APIs, including norgestrel, with high purity standards.

c. Aurobindo Pharma
A major Indian API manufacturer that produces norgestrel API at scale, meeting international regulatory standards.

d. Dr. Reddy’s Laboratories
India-based pharmaceutical company supplying norgestrel API to global markets, adhering to cGMP guidelines.

e. Shanghai Hanhong Pharmaceutical Co., Ltd.
A Chinese API manufacturer producing norgestrel for export and domestic use.

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Regulatory Standards and Compliance

Suppliers listed primarily adhere to Good Manufacturing Practice (GMP) standards as mandated by regulators such as the FDA (United States), EMA (Europe), and other national agencies. Ensuring regulatory compliance is critical for quality assurance and market approval.

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Supply Chain Considerations

• Market Demand and Supply Security: The contraceptive market’s steady demand ensures continuous supply, yet disruptions in key API sources or manufacturing facilities can impact availability.
• Cost Factors: API costs influence the price of LOW-OGESTREL-21; suppliers in India and China often provide competitive rates.
• Regulatory Approvals: Suppliers must meet regional regulatory requirements, impacting international sourcing decisions.

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Conclusion and Strategic Implications

Global suppliers of LOW-OGESTREL-21 leverage extensive manufacturing capacity, with prominent players including Bayer, Teva, Mylan, Sandoz, and Richter. The API supply chain relies heavily on Chinese and Indian manufacturers capable of producing high-quality norgestrel. Contract manufacturing organizations like Patheon and Almac support the production process, providing additional flexibility and capacity.

For healthcare organizations and pharmaceutical companies seeking reliable sources, prioritizing suppliers with proven regulatory compliance, robust quality controls, and proven distribution capabilities is critical. The market is characterized by intense competition, with cost efficiency and supply stability driving procurement strategies.

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Key Takeaways

• The primary suppliers of LOW-OGESTREL-21 are leading global pharmaceutical manufacturers such as Teva, Mylan, Sandoz, and Bayer, often supplemented by contract manufacturing organizations (CMOs).
• High-quality norgestrel API is predominantly supplied by Chinese and Indian manufacturers, with notable producers like Zhejiang Sanyou and Aurobindo Pharma.
• Regulatory compliance and GMP standards are critical factors influencing supplier credibility and market access.
• Supply chain stability is vital; manufacturers should diversify sourcing to mitigate risks related to geopolitical, regulatory, or manufacturing disruptions.
• Cost considerations heavily influence procurement, especially from Asian API suppliers, making China and India dominant in API production for hormonal contraceptives.

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FAQs

1. Are LOW-OGESTREL-21 suppliers regulated under international standards?
Yes, leading suppliers adhere to stringent GMP guidelines mandated by agencies like the FDA and EMA, ensuring quality and safety.

2. Can supply disruptions affect the availability of LOW-OGESTREL-21?
Potentially, especially if reliant on a limited number of API sources or manufacturing facilities. Diversification and robust supply agreements mitigate this risk.

3. Do regional regulations impact supplier choices for LOW-OGESTREL-21?
Absolutely. Suppliers must comply with regional standards such as FDA approval in the U.S. or EMA certifications in Europe, which influence procurement decisions.

4. Are generic LOW-OGESTREL-21 formulations bioequivalent to branded versions?
Yes, provided they meet bioequivalence standards set by regulatory agencies, ensuring similar efficacy and safety.

5. What role do Contract Manufacturing Organizations play in the LOW-OGESTREL-21 supply chain?
CMOs enable scalability, cost reduction, and flexibility in manufacturing, often producing finished tablets or even active ingredients under contract for various pharmaceutical firms.

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Sources:

1. [1] U.S. Food and Drug Administration (FDA) – Active Pharmaceutical Ingredient (API) Regulations.
2. [2] European Medicines Agency (EMA) – Quality Standards for Hormonal Contraceptives.
3. [3] PharmTech – Role of Contract Manufacturing Organizations in Contraceptive Production.
4. [4] Global Data – Market Analysis for Oral Contraceptives.
5. [5] Sourcing Industry Group (SIG) – API Supplier Directories and Compliance Reports.