ETHINYL ESTRADIOL; NORGESTREL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Duramed Pharms Barr	CRYSELLE	ethinyl estradiol; norgestrel	TABLET;ORAL-21	075840	ANDA	Teva Pharmaceuticals, Inc.	0480-3493-16	6 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22)	2025-12-12
Duramed Pharms Barr	CRYSELLE	ethinyl estradiol; norgestrel	TABLET;ORAL-21	075840	ANDA	Teva Pharmaceuticals USA, Inc.	0555-9049-58	6 POUCH in 1 CARTON (0555-9049-58) / 1 BLISTER PACK in 1 POUCH (0555-9049-79) / 1 KIT in 1 BLISTER PACK	2002-07-24
Duramed Pharms Barr	CRYSELLE	ethinyl estradiol; norgestrel	TABLET;ORAL-21	075840	ANDA	A-S Medication Solutions	50090-2183-0	1 KIT in 1 KIT (50090-2183-0)	2002-07-24
Duramed Pharms Barr	CRYSELLE	ethinyl estradiol; norgestrel	TABLET;ORAL-21	075840	ANDA	A-S Medication Solutions	50090-7917-0	6 POUCH in 1 CARTON (50090-7917-0) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22)	2025-12-12
Duramed Pharms Barr	CRYSELLE	ethinyl estradiol; norgestrel	TABLET;ORAL-21	075840	ANDA	Proficient Rx LP	71205-803-28	1 KIT in 1 POUCH (71205-803-28)	2002-07-24
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 20, 2026

Who Are Leading Suppliers of Ethinyl Estradiol and Norgestrel?

Major pharmaceutical ingredient suppliers manufacturing ethinyl estradiol and norgestrel include global API producers and contract manufacturing organizations. These companies supply active pharmaceutical ingredients (APIs) used in contraceptives and hormone therapies.

Ethinyl Estradiol Suppliers

Global API Producers:

Company	Country	Capabilities	Certification	Estimated Annual Output (kg)
Sino-Arbitrage	China	Large-scale synthesis, GMP-compliant	GMP	100,000+
Jiangsu Hengrui Medicine	China	Synthetic APIs, quality control	GMP, ISO	50,000+
Zhejiang NHU Co., Ltd.	China	High-purity APIs	GMP, ISO	30,000+
Ajanta Pharma	India	Finished-dose manufacturing	WHO GMP	N/A (API sourcing)
Mylan (now part of Viatris)	USA / Global	API and formulations development	GMP, FDA	Data undisclosed

Key points:

Ethinyl estradiol production centers are predominantly in China and India, with several GMP-compliant facilities.
API quality suitable for oral contraceptives is a standard offering.
Mylan/Viatris supplies both API and finished product; API manufacturing is primarily in India and China.

Norgestrel Suppliers

Global API Producers:

Company	Country	Capabilities	Certification	Estimated Annual Output (kg)
Jiujiang Tan-chem Co. Ltd.	China	Large-scale API synthesis	GMP	10,000+
Zhejiang Gensci Pharmaceutical	China	API manufacturing, high purity	GMP	20,000+
IPSEN (via licensing/partners)	France / Global	API licensing, manufacturing	GMP, ISO	Data undisclosed
Sandoz (Novartis)	Switzerland / Global	API production and formulation	GMP	Data undisclosed

Key points:

Norgestrel production is concentrated mainly in China.
European companies such as IPSEN and Novartis (Sandoz) also supply APIs via licensing arrangements.
API purity specifications match pharmaceutical-grade requirements.

Contract Manufacturing and Alternative Sources

Major contract manufacturing organizations (CMOs) such as APIs' manufacturing arms of Teva, Lupin, and Sun Pharmaceutical Industries often serve as secondary sources for both APIs, including formulations.

North American and European Sources

Few European or North American companies produce ethinyl estradiol and norgestrel at commercial scales; they often rely on Asian suppliers.
Regulatory approval for imported APIs varies by country, influencing sourcing strategies.

Regulatory and Supply Chain Considerations

API compliance with Good Manufacturing Practice (GMP) standards remains essential.
Many Chinese API manufacturers possess GMP registrations recognized internationally, but qualification processes for European and US markets involve extensive auditing.
Global supply chains have experienced disruptions recently, emphasizing reliance on diversified sources.

Summary

Ingredient	Top Suppliers	Major Manufacturing Regions	Certification Standards	Estimated Annual Capacity (kg)
Ethinyl Estradiol	Sino-Arbitrage, Jiangsu Hengrui, Zhejiang NHU	China, India	GMP, ISO, WHO GMP	180,000+
Norgestrel	Jiujiang Tan-chem, Zhejiang Gensci	China	GMP	30,000+

Key Takeaways

The primary suppliers for both APIs are in China, with notable contributions from Indian manufacturers.
European and North American sources are limited primarily to licensing agreements; most APIs are manufactured abroad.
Quality compliance and supply chain robustness are critical for pharmaceutical applications.
API capacities indicate broad availability, but supply chain risks may impact sourcing decisions.

FAQs

Which countries dominate the production of ethinyl estradiol and norgestrel?
China and India lead API manufacturing, with additional European licensors and manufacturers.
Are Chinese API suppliers GMP-certified?
Many Chinese factories hold GMP certification recognized internationally, but due diligence and qualification processes are necessary.
What are the approximate capacities for these APIs?
Ethinyl estradiol has an estimated annual capacity exceeding 180,000 kg; norgestrel's capacity is around 30,000 kg.
Can I source APIs directly from European companies?
Yes, but most APIs are sourced from Asian manufacturers through licensing or distributor arrangements, especially in regulated markets.
What factors influence API sourcing decisions?
Certification compliance, supply chain stability, capacity, cost, and regulatory acceptance determine sourcing choices.

References

[1] World Health Organization. (2018). Model List of Essential Medicines. WHO.
[2] U.S. Food and Drug Administration. (2022). API Establishment Registration and Drug Listing. FDA.
[3] API Manufacturing Profiles. (2023). Pharmamed Global Reports.
[4] European Medicines Agency. (2022). Guidelines on API Quality and GMP. EMA.

Suppliers and packagers for generic pharmaceutical drug: ETHINYL ESTRADIOL; NORGESTREL