Suppliers and packagers for PROPECIA

PROPECIA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	PROPECIA	finasteride	TABLET;ORAL	020788	NDA	Organon LLC	78206-152-01	30 TABLET, FILM COATED in 1 BOTTLE (78206-152-01)	2021-06-01
Organon	PROPECIA	finasteride	TABLET;ORAL	020788	NDA	Organon LLC	78206-152-02	90 TABLET, FILM COATED in 1 BOTTLE (78206-152-02)	2021-06-01

Suppliers and packagers for PROPECIA

Last updated: April 25, 2026

Who Supplies PROPECIA (Finasteride) and What Is Known From Public Data?

What is PROPECIA?

PROPECIA is the brand name for finasteride (oral; 1 mg). Finasteride is a synthetic 4-aza-steroid that inhibits type II 5α-reductase, lowering conversion of testosterone to dihydrotestosterone (DHT). PROPECIA is widely marketed by multiple jurisdictions under brand licensing or generic manufacturing agreements, depending on patent status and local regulatory pathways.

Key point for supplier mapping: branded “PROPECIA” supply chains vary by country and can shift quickly as generics and contract manufacturers enter. Public-facing supplier identification is usually published at the regulator label/marketing authorization level (who is “MAH” or “marketing authorization holder” / “holder of authorization”) and at the product label level (who is listed as manufacturer/packager).

Who supplies PROPECIA in practice?

Across most markets, PROPECIA supply comes from two layers:

1. Marketing authorization holders (MAH) / branded license holders that control the brand registration and labeling in a country.
2. API and finished-dose manufacturers used under contract manufacturing (CMO) or direct manufacturing agreements.

For business decisions (procurement, sourcing risk, and R&D competitive intelligence), the actionable supplier list is the set of entities named on the product’s regulatory label and packaging: MAH/labeler, finished-dose manufacturer(s), and packer(s).

What suppliers are publicly tied to finasteride (the active) vs PROPECIA (the brand)?

Public procurement and regulatory listings often mix these layers:

• API suppliers are typically listed in DMF (Drug Master File) systems in the US, where access depends on confidentiality and registration structure.
• Finished-dose manufacturers for finasteride products (brand and generic) are commonly listed in regulatory databases and label inserts, but PROPECIA-specific “named supplier” data is jurisdiction-dependent and label-dependent.

Result: Without a specific jurisdiction and product strength/form (for example, “PROPECIA 1 mg tablets” in the UK vs “PROPECIA 1 mg tablets” in Canada vs “PROPECIA 1 mg tablets” in the US), supplier identification cannot be completed to a single accurate list.

What can be stated from authoritative regulatory and product-identity data?

• Brand product identity: PROPECIA corresponds to finasteride 1 mg oral tablets. (Product identity and active substance are consistent across markets.)
• Regulatory pathways: PROPECIA is supported through branded marketing authorizations in many countries; generic finasteride products are regulated via local generic pathways (bioequivalence and quality requirements).

These facts support supplier mapping to MAH/labeler and manufacturing sites, but they do not name a single global supplier set.

Actionable supplier mapping framework for PROPECIA procurement

How to identify actual “suppliers” that matter for sourcing

Use the following label fields as the supplier shortlist:

• Marketing Authorization Holder (MAH) / Labeler (brand control in that country)
• Manufacturer (site that produces tablets)
• Batch release and/or packer (often a different site)

In many pharma supply chains, one or more of these roles changes with manufacturing campaigns.

Key Takeaways

• PROPECIA is finasteride 1 mg tablets; supplier lists for “PROPECIA” are country- and label-dependent.
• A complete, accurate supplier list must be extracted from jurisdiction-specific regulatory label/MAH/manufacturer fields.
• Publicly available global lists that claim a single set of “PROPECIA suppliers” are typically unreliable because labelers and manufacturing sites differ by market and over time.

FAQs

1. Is the supplier of PROPECIA the same as the supplier of finasteride API?
   No. API suppliers are often different entities from finished-dose tablet manufacturers and labelers.

2. Why do PROPECIA suppliers vary by country?
   Marketing authorization holders and contracted manufacturers differ based on local regulatory filings, licensing, and supply agreements.

3. What supplier names should be used for procurement risk control?
   The MAH/labeler plus the named tablet manufacturer(s) and packer(s) on the product label in the target jurisdiction.

4. Does PROPECIA always use the same manufacturing site?
   No. Sites can change by batch, contract refresh, or lifecycle management under the same marketing authorization.

5. Can finasteride generics be supplied by the same manufacturers as PROPECIA?
   Often yes, at the finished-dose level, but the branded labeler/MAH and the exact manufactured product specification can differ.

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References

[1] FDA. Drug Approval Package: Propecia (finasteride). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book): finasteride (1 mg). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
[3] European Medicines Agency (EMA). Public product information and EPAR records for finasteride-containing medicinal products. https://www.ema.europa.eu/