LEVONORGESTREL AND ETHINYL ESTRADIOL: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glenmark Pharms Ltd	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	202791	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-637-29	3 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH (68462-637-84) / 28 TABLET in 1 BLISTER PACK	2015-04-09
Glenmark Pharms Ltd	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203164	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-672-95	3 POUCH in 1 CARTON (68462-672-95) / 1 BLISTER PACK in 1 POUCH (68462-672-91) / 1 KIT in 1 BLISTER PACK	2015-06-12
Lupin Ltd	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	091440	ANDA	Lupin Pharmaceuticals, Inc.	68180-843-13	3 BLISTER PACK in 1 CARTON (68180-843-13) / 1 KIT in 1 BLISTER PACK	2012-10-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 4, 2026

Suppliers for levonorgestrel and ethinyl estradiol span (1) API manufacturers for hormonal active pharmaceutical ingredients, (2) custom chemical suppliers for key steroid intermediates and linking steps, and (3) contract manufacturers (CDMOs) that produce finished oral contraceptives (OCs) in tablet strengths such as 0.1 mg/0.02 mg, 0.15 mg/0.03 mg, and 0.25 mg/0.035 mg. The procurement surface depends on whether you need regulated APIs for NDA/ANDA supply, or commercial-market APIs for re-labeled products.

Which companies supply levonorgestrel and ethinyl estradiol APIs for pharma customers?

Featured suppliers for levonorgestrel and ethinyl estradiol appear in three categories: API producers (chemical manufacturing of the hormones), intermediate manufacturers (steroid chemistry supply chain), and CDMOs that formulate and package combined oral contraceptives.

API manufacturers: levonorgestrel (typical roles and capabilities)

Levone gestrel is a synthetic progestin produced via steroid chemistry routes (multi-step transformations, chiral intermediates, and controlled oxidation/reduction steps). API suppliers typically provide:

DMF-ready chemistry packages for regulatory submissions
cGMP manufacturing at API or intermediates scales
polymorph and impurity control packages
stability data suitable for oral solid dose markets

Common supplier footprints in the market include large Indian and Chinese API manufacturers and specialized steroid-chemistry producers. (Exact supplier lists vary by geography, grade, and regulatory status.)

API manufacturers: ethinyl estradiol (typical roles and capabilities)

Ethinyl estradiol is a semi-synthetic estrogen made via estrone/estradiol-derived routes with key steps introducing the ethinyl group and controlling oxidation state and impurity profiles. API suppliers typically provide:

cGMP API supply with impurity specifications aligned to pharmacopeia and customer requirements
impurity profiling (especially related substances linked to upstream steroid starting materials)
batch traceability for hormonal APIs

Where API suppliers intersect: regulatory and quality documentation

For hormone APIs used in NDAs/ANDAs, procurement usually hinges on the supplier’s:

DMF status or Letter of Access pathway
ability to support regulatory queries (HPLC methods, impurity qualification narrative)
GMP certificates, audit history, and change control governance

Practical sourcing implication: if your goal is regulatory-ready supply, you typically prioritize suppliers that have existing DMF/ASMF pathways for levonorgestrel and ethinyl estradiol (or have LOA relationships already used in the market).

What finished-dosage form CDMOs produce levonorgestrel and ethinyl estradiol tablets?

CDMOs for combined oral contraceptives produce:

film-coated tablets or coated tablets
fixed-dose combinations of levonorgestrel + ethinyl estradiol in multiple strengths
blister and bottle packaging lines, plus labeling support

Typical tablet strengths in the market

Many commercial OCs using these hormones are in these strength ranges:

Levonorgestrel 0.1 mg + Ethinyl estradiol 0.02 mg
Levonorgestrel 0.15 mg + Ethinyl estradiol 0.03 mg
Levonorgestrel 0.25 mg + Ethinyl estradiol 0.035 mg

CDMO selection drivers for combined OCs

CDMO qualification for these products usually focuses on:

blending and content uniformity for low-dose estrogen
tablet hardness/film-coat stability and dissolution performance
handling and segregation of hormonal powders
packaging validation for blister or HDPE bottle formats
stability protocol alignment to ICH requirements

Which suppliers provide key intermediates in levonorgestrel and ethinyl estradiol synthesis?

The supply chain for hormonal APIs often involves:

steroid starting materials and early intermediates (estrone, estradiol derivatives, and related ketones)
side-chain introduction steps for progestin formation
introduction of ethinyl group for ethinyl estradiol
final oxidation state adjustment and purification to meet hormonal impurity specifications

Intermediate-supplier roles

Intermediate suppliers provide:

GMP-grade steroid intermediates to API manufacturers
specialized chiral intermediates where stereochemistry control is critical
customized intermediate scale-up and analytical method transfer packages

Procurement implication

For sourcing strategy, intermediate suppliers matter because they often determine:

impurity profiles and batch-to-batch consistency for the finished API
supply resilience during demand surges or manufacturing turnarounds
regulatory defensibility in DMF content

How do supplier lists differ by region (US, EU, India, China)?

Supplier presence varies by regulatory penetration and DMF/ASMF coverage.

United States procurement (NDA/ANDA pathway focus)

In the US, the highest-friction procurement usually concerns whether the API supplier:

holds an FDA DMF or has a usable LOA history
can support inspections and respond to FDA information requests
meets US-specific GMP expectations and method validation requirements

Europe procurement (CEP/EMA-aligned expectations)

In the EU, procurement often emphasizes:

compliance with EMA expectations via ASMF/CEP pathways
batch release testing congruent with European pharmacopoeia specs
audit readiness for EU GMP expectations

India and China procurement (cost and scaling)

India and China often lead on:

price competitiveness for API and intermediate supply
capacity scale and repeatability for commercial production
a broad supplier base for non-US/less-regulated markets

Key sourcing point: the “best” supplier set for cost can change materially if the product needs US DMF alignment or EU ASMF/CEP-backed compliance.

What is the supplier landscape for contract manufacturing of combined oral contraceptives?

CDMOs that support OC tablets typically run:

oral solid dose lines (blending, compression, coating, packaging)
quality systems with hormonal segregation controls
stability chambers and validated dissolution testing

Manufacturing/IP risk considerations

For combined OCs, supplier selection should also consider:

whether the CDMO is engaged in manufacturing branded or generic equivalents
how compounding steps interact with formulation IP (coating system, excipient choices, process controls)

Which suppliers are active in ANDA supply chains for levonorgestrel/ethinyl estradiol combinations?

In practice, ANDA supply chains commonly consolidate around:

a small set of qualified API manufacturers with demonstrated regulatory submissions
a small set of formulation CDMOs with prior content-uniformity and dissolution performance for these hormone pairs

Procurement implication: if you need to support fast ANDA execution, you typically target suppliers that already ship these hormones for generic oral contraceptives and that can align documentation quickly.

How to structure an effective sourcing plan for levonorgestrel and ethinyl estradiol?

A high-speed plan separates procurement into three tracks:

API supply

API manufacturer with regulatory documentation pathway (DMF/ASMF/LOA readiness)
ability to match exact grade used in your reference product or target specification profile

Tablet CDMO

CDMO experienced in low-dose estrogen content uniformity and film coating
packaging format capability (blister vs bottle) aligned to your labeling and supply chain

Intermediate continuity

confirm backup sources for key intermediates or starting materials
ensure batch impurity and spec consistency across alternate supply

Sourcing deliverables buyers typically require

GMP certificates and audit reports for API and intermediates
CoA template with impurity tables
method summaries for key impurities and release testing
change notification policy and scale-up tech transfer confirmation
stability commitment compatible with your proposed shelf life

Key Takeaways

Levonorgestrel and ethinyl estradiol supply is typically split across API producers, steroid intermediate suppliers, and CDMOs that produce combined OC tablets.
Supplier selection is driven less by the molecule alone and more by documentation readiness (DMF/ASMF/LOA), impurity control capability, and low-dose content-uniformity performance.
For commercial and regulatory execution, procurement should be planned as a three-track system: API, tablet manufacturing, and intermediate continuity, with clear specifications and change-control governance.

FAQs

1) What documentation should an API supplier provide for levonorgestrel and ethinyl estradiol?

DMF/ASMF readiness, LOA history (if applicable), CoA with impurity tables, release test methods, and batch traceability package are standard prerequisites for regulatory-grade procurement.

2) Can one supplier provide both levonorgestrel and ethinyl estradiol APIs?

Yes, some API manufacturers supply both hormones, but buyers often dual-source to protect continuity given steroid chemistry batch cycle risks.

3) What tablet manufacturing constraints matter most for combined oral contraceptives?

Content uniformity at low estrogen dose, blending repeatability, film-coat process control, and dissolution performance under validated manufacturing conditions.

4) Who supplies the steroid intermediates behind these APIs?

Intermediate suppliers provide steroid-derived ketones and side-chain and ethinyl introduction intermediates used by API manufacturers under GMP and controlled impurity regimes.

5) Are packaging and labeling capabilities part of CDMO selection for these products?

Yes. Blister and bottle packaging validation, line clearance for hormonal materials, and labeling execution are typical selection criteria for OC supply.

References

U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMF). https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-master-files-dmf
European Medicines Agency. (n.d.). Active Substance Master File (ASMF). https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/active-substance-master-file-asmf
U.S. Pharmacopeia and National Formulary. (n.d.). USP-NF monographs (as applicable to levonorgestrel and ethinyl estradiol). https://www.uspnf.com/

Suppliers and packagers for LEVONORGESTREL AND ETHINYL ESTRADIOL