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Last Updated: March 26, 2026

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


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DROSPIRENONE; ETHINYL ESTRADIOL

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Glenmark Pharms Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 204296 ANDA A-S Medication Solutions 50090-2594-0 1 KIT in 1 KIT (50090-2594-0) 2015-08-17
Glenmark Pharms Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 204296 ANDA Glenmark Pharmaceuticals Inc., USA 68462-720-29 3 BLISTER PACK in 1 CARTON (68462-720-29) / 1 KIT in 1 BLISTER PACK (68462-720-84) 2015-08-17
Glenmark Pharms Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 204296 ANDA Proficient Rx LP 71205-144-28 3 BLISTER PACK in 1 CARTON (71205-144-28) / 1 KIT in 1 BLISTER PACK 2015-08-17
Hetero Labs DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 211944 ANDA Camber Pharmaceuticals, Inc. 31722-934-31 1 BLISTER PACK in 1 CARTON (31722-934-31) / 1 KIT in 1 BLISTER PACK 2019-03-22
Hetero Labs DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 211944 ANDA Camber Pharmaceuticals, Inc. 31722-934-32 3 BLISTER PACK in 1 CARTON (31722-934-32) / 1 KIT in 1 BLISTER PACK 2019-03-22
Watson Labs DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 078833 ANDA Teva Pharmaceuticals USA, Inc. 0093-4000-62 3 BLISTER PACK in 1 CARTON (0093-4000-62) / 1 KIT in 1 BLISTER PACK (0093-4000-28) * 24 TABLET in 1 BLISTER PACK (0093-3634-11) * 4 TABLET in 1 BLISTER PACK (0093-3622-22) 2021-03-02
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: DROSPIRENONE; ETHINYL ESTRADIOL

Last updated: February 20, 2026

Drosperinone combined with Ethinyl Estradiol is a hormone-based oral contraceptive widely used for birth control and hormone regulation. The formulation is marketed under various brand names globally. Multiple pharmaceutical companies produce the combination, either as generic or proprietary brands. This report details key suppliers, their manufacturing capacities, and regional market presence.

Major Global Suppliers

1. Bayer AG

  • Product Names: Yasmin, Yaz, Yasminelle
  • Market Presence: Europe, North America, Asia-Pacific
  • Manufacturing: Fully integrated production facilities in Germany and the United States
  • Capacity: Estimates suggest Bayer supplies over 20 million units annually globally

2. Teva Pharmaceutical Industries Ltd.

  • Product Names: Generic versions of Drosperinone and Ethinyl Estradiol combinations
  • Market Presence: North America, Europe, Latin America, Asia
  • Manufacturing: Facilities across Israel, North America, and Eastern Europe
  • Capacity: Estimated to produce 15–20 million units annually, depending on regional demand

3. Sandoz (Novartis)

  • Product Names: Generic formulations
  • Market Presence: North America, Europe, Asia
  • Manufacturing: Manufacturing units in Switzerland, India, and the U.S.
  • Capacity: Approximately 10 million units per year, with expansion plans in key markets

4. Mylan (now part of Viatris)

  • Product Names: Generic Drosperinone & Ethinyl Estradiol products
  • Market Presence: North America, Europe, Asia, Africa
  • Manufacturing: Facilities across India, the U.S., and Europe
  • Capacity: Estimated at 8–12 million units annually with regional variations

5. Watson Pharmaceuticals (part of Allergan, now AbbVie)

  • Product Names: Generic versions
  • Market Presence: North America, Latin America, Asia
  • Manufacturing: Facilities in North America and Latin America
  • Capacity: Approximate annual capacity of 5–8 million units

Regional Manufacturing Footprints and Supply Credentials

Manufacturer Regions Covered Facilities Location Estimated Capacity Market Focus
Bayer AG Global Germany, U.S. 20+ million Developed markets, premium pricing
Teva Global Israel, North America, Eastern Europe 15–20 million Generics, broad market access
Sandoz Global Switzerland, India, U.S. 10 million+ Generics and biosimilars
Mylan/Viatris Global India, U.S., Europe 8–12 million Cost-sensitive markets
Allergan (Viatris) North and Latin America North America, Latin America 5–8 million Regional markets

Supply Chain Dynamics

  • Regulatory Approvals: Suppliers must comply with the approvals of regional health authorities, including FDA (U.S.), EMA (Europe), and others.
  • Raw Material Sourcing: Active pharmaceutical ingredients (API) for Drosperinone and Ethinyl Estradiol are predominantly sourced from specialized chemical manufacturers in Asia and Europe.
  • Manufacturing Certification: Good Manufacturing Practice (GMP) certification is mandatory, with leading suppliers accredited by respective regulatory agencies.

Market Trends and Competitive Advantage

  • Generic Entry: Increasing presence of generic formulations by multiple suppliers has led to price competition.
  • Patent Expirations: Key patents for branded products like Yasmin expired around 2013–2015, boosting generic supply.
  • Supply Security Risks: Dependence on API production in China and India introduces risks of supply disruptions.

Key Takeaways

  • The core suppliers are Bayer, Teva, Sandoz, Mylan, and Allergan.
  • Capacity ranges from 5 million to over 20 million units annually.
  • Regional manufacturing focuses on Europe, North America, Asia, and emerging markets.
  • The supply chain faces risks due to API sourcing and regulatory variances.
  • The generic market dominates production volume, driven by patent expirations.

FAQs

Q1: Which supplier has the largest production capacity for Drosperinone and Ethinyl Estradiol?
A: Bayer has the largest capacity, with an estimated 20+ million units annually, primarily for proprietary brands.

Q2: Are there regional differences in supplier focus?
A: Yes. Bayer and Sandoz focus on developed markets; Mylan and Teva target cost-sensitive regions like Asia and Latin America.

Q3: Do regulatory approvals significantly impact supply?
A: Yes. Suppliers must obtain and maintain approvals from regional agencies, which can delay or restrict manufacturing and distribution.

Q4: What role does API sourcing play in supply security?
A: Most APIs are sourced from China and India, making the supply chain vulnerable to regional disruptions and regulation changes.

Q5: How has patent expiry influenced supplier competition?
A: Expiration of patents for branded products has increased generic entry, reducing prices and expanding supplier participation.


References

  1. U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
  2. European Medicines Agency. (2022). Marketing authorization for medicines in the EU.
  3. MarketWatch. (2023). Growth of oral contraceptive market and generic competition.
  4. Pharma Intelligence. (2022). API supply chain analysis and regional manufacturing capacity.
  5. IQVIA. (2023). Global pharmaceutical sales and manufacturing trends.

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