Last Updated: May 11, 2026

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


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ETHINYL ESTRADIOL; LEVONORGESTREL

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017 NDA Agile Therapeutics, Inc. 71671-100-01 1 POUCH in 1 CARTON (71671-100-01) / 1 PATCH in 1 POUCH (71671-100-11) 2020-09-11
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017 NDA Agile Therapeutics, Inc. 71671-100-03 3 POUCH in 1 CARTON (71671-100-03) / 1 PATCH in 1 POUCH (71671-100-11) 2020-09-11
Glenmark Pharms Ltd ASHLYNA ethinyl estradiol; levonorgestrel TABLET;ORAL 203163 ANDA A-S Medication Solutions 50090-2097-0 1 KIT in 1 KIT (50090-2097-0) 2015-02-23
Glenmark Pharms Ltd ASHLYNA ethinyl estradiol; levonorgestrel TABLET;ORAL 203163 ANDA Glenmark Pharmaceuticals Inc., USA 68462-646-93 2 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91) 2015-02-23
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Suppliers and packagers for generic pharmaceutical drug: ETHINYL ESTRADIOL; LEVONORGESTREL

Last updated: April 25, 2026

Who Supplies Ethinyl Estradiol and Levonorgestrel for Pharma Use?

Which suppliers manufacture or supply Ethinyl Estradiol?

Ethinyl estradiol is widely supplied globally as an active pharmaceutical ingredient (API) and also as finished-dose components for oral contraceptives and related hormone products. Commercial supply is dominated by large generic API producers and specialized hormone-API firms. Commonly cited supply-chain operators in the global market include:

  • Hangzhou Verid Pharmaceutical (China)
  • Hubei Runda Pharmaceutical (China)
  • Jiangsu Simcere Pharmaceutical (China)
  • Luqiao Pharmaceutical (China)
  • Syncom Formulations India (India)

Typical use cases in product portfolios

  • Combined oral contraceptives (COCs) using ethinyl estradiol with a progestin (often levonorgestrel)
  • Hormone preparations requiring a standard estrogen component

Which suppliers manufacture or supply Levonorgestrel?

Levonorgestrel is also a high-volume progestin API used in COCs and levonorgestrel-based contraceptives. The supplier base overlaps with ethinyl estradiol producers and includes specialized steroid API manufacturers.

Commonly cited suppliers in the global market include:

  • Hangzhou Verid Pharmaceutical (China)
  • Hubei Runda Pharmaceutical (China)
  • Sichuan Tongsheng Pharmaceutical (China)
  • Jiangsu Simcere Pharmaceutical (China)
  • Syncom Formulations India (India)

Typical use cases in product portfolios

  • Levonorgestrel-containing COCs
  • Emergency contraception formulations (depending on local authorization and product design)

What else should you treat as “supplier-relevant” for these APIs?

For procurement and regulatory readiness, supplier identification is not only about API manufacturers. It often includes:

  1. Contract manufacturers that finish APIs into compliant drug-product intermediates
  2. Formulation/packaging sites for final tablet production
  3. Distributor networks that hold marketable inventory and provide documentation packages (CoA, DMF/CEP-linked dossiers where applicable)

Supplier Map Summary (API Layer)

API Supplier category Commonly referenced supplier names
Ethinyl estradiol API manufacturer Hangzhou Verid Pharmaceutical; Hubei Runda Pharmaceutical; Jiangsu Simcere Pharmaceutical; Luqiao Pharmaceutical; Syncom Formulations India
Levonorgestrel API manufacturer Hangzhou Verid Pharmaceutical; Hubei Runda Pharmaceutical; Sichuan Tongsheng Pharmaceutical; Jiangsu Simcere Pharmaceutical; Syncom Formulations India

Key Takeaways

  • Ethinyl estradiol and levonorgestrel are both supplied by a broad set of China- and India-based API producers plus global generic supply-chain operators.
  • The most visible supplier names in the market overlap across both APIs, especially Hangzhou Verid Pharmaceutical and Hubei Runda Pharmaceutical, with Simcere also recurring.
  • Supplier qualification in practice depends on documentation readiness (DMF/CEP linkage, CoA traceability) and not only on whether a company lists the API in catalogs.

FAQs

1) Are ethinyl estradiol and levonorgestrel typically sourced from the same supplier?

In many commercial supply chains, yes. Several API producers list both APIs, enabling procurement consolidation.

2) Do suppliers provide both API and finished contraceptive intermediates?

Some firms supply only API, while others support contract manufacturing of drug-product intermediates or finished dosage forms. The distinction is company-specific.

3) Which region dominates API supply for these hormones?

China and India account for a large share of market-visible API manufacturing capacity for steroid hormones.

4) What documents matter most when buying these APIs?

Procurement typically focuses on CoA and dossier compatibility (DMF or equivalent regulatory documentation) tied to the intended market.

5) Do supplier lists change frequently for these high-volume APIs?

Yes. Supplier availability and regulatory status shift with manufacturing authorizations, inspection outcomes, and portfolio changes.


References

  1. European Medicines Agency. European database of medicines (products and substances). EMA. https://www.ema.europa.eu/
  2. U.S. FDA. Drugs@FDA (product labeling information used to infer substance use and references). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
  3. European Directorate for the Quality of Medicines (EDQM). CEP-related information and substance quality documentation (context for API sourcing frameworks). EDQM. https://www.edqm.eu/
  4. World Health Organization (WHO). Quality assurance and API guidance (procurement documentation concepts). WHO. https://www.who.int/teams/health-product-policy-standards-and-compliance/quality-assurance
  5. PubChem, U.S. National Library of Medicine. Compound records for ethynyl estradiol and levonorgestrel (substance identity baseline). NIH. https://pubchem.ncbi.nlm.nih.gov/

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