Last Updated: May 10, 2026

Suppliers and packagers for CYTOTEC


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CYTOTEC

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268 NDA Pfizer Laboratories Div Pfizer Inc 0025-1451-34 100 BLISTER PACK in 1 CARTON (0025-1451-34) / 1 TABLET in 1 BLISTER PACK 1986-12-27
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268 NDA Pfizer Laboratories Div Pfizer Inc 0025-1451-60 60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1451-60) 1986-12-27
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268 NDA Pfizer Laboratories Div Pfizer Inc 0025-1461-31 100 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-31) 1986-12-27
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268 NDA Pfizer Laboratories Div Pfizer Inc 0025-1461-60 60 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-60) 1986-12-27
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 59762-5007-1 60 TABLET in 1 BOTTLE (59762-5007-1) 2009-12-27
Pfizer CYTOTEC misoprostol TABLET;ORAL 019268 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 59762-5007-2 120 TABLET in 1 BOTTLE (59762-5007-2) 2009-12-27
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for CYTOTEC

Last updated: April 25, 2026

Who Supplies Cytotec (Misoprostol) to Pharmacies and Wholesalers?

Cytotec is the brand name for misoprostol. In most markets, “Cytotec suppliers” in practice means (1) the branded manufacturer/MAH for Cytotec and (2) the downstream companies that import, distribute, or manufacture misoprostol generics under local authorizations. Supply chain details vary by country and channel (hospital tender vs retail pharmacy vs government procurement), but the supplier categories are consistent.

What counts as a “Cytotec supplier”?

Supply role Typical entity type What it provides
Branded product MAH/manufacturer Brand owner and/or contract manufacturer Cytotec misoprostol tablets under the Cytotec label
Importer or authorized distributor Licensed pharmaceutical distributor/wholesaler Product movement from manufacturer/MAH to regional wholesalers
Generic manufacturer Companies producing misoprostol under local marketing authorization Misoprostol tablets labeled as generic or under local brands
Hospital procurement vendor Tender/channel-specific distributors Misoprostol product allocation to hospitals and clinics

Which companies supply Cytotec brand misoprostol?

Is there a single global Cytotec branded supplier?

No. Cytotec supply is not controlled by one universally named “supplier” across all jurisdictions. The branded product is marketed through local marketing authorizations and distribution networks. The actual labeled supplier on a given package depends on the country’s MAH, local importer, and approved packaging configuration.

How misoprostol brand-to-generic supply typically works

Cytotec’s branded availability tends to be supported by:

  • Branded supply contracts with local distributors for continuity of stock.
  • Parallel generic supply (misoprostol under multiple local brand names and strengths), which can dominate volume where authorized generics are permitted and priced lower.

How to identify the actual “supplier” for a specific Cytotec product line

What to look for on the pack

For any Cytotec product in a given country, the “supplier” is usually indicated by one or more of the following on the carton or blister:

  • Marketing Authorization Holder (MAH)
  • Manufacturer (sometimes the same legal entity as MAH, sometimes a contract manufacturer)
  • Importer/Local distributor (if applicable)
  • Batch/lot and labeling address

What data points matter for procurement

Procurement teams typically validate:

  • Strength (misoprostol tablet strength varies by market)
  • Dosage form (tablets)
  • Storage conditions
  • Regulatory authorization in-country
  • Lot traceability

Generic misoprostol supply: who manufactures it?

What does the misoprostol generic landscape look like?

Misoprostol generics exist broadly because the API is no longer protected by strong exclusivity in many markets, and multiple manufacturers can file abbreviated dossiers where permitted.

Common supplier patterns for misoprostol

Supplier type Typical origin pattern Business impact
API-to-tablet integrated manufacturers API production plus tablet finishing More control on yield and impurity profiles
Tablet-only contract manufacturers Finish tablets from purchased API Faster scaling but depends on API supply continuity
Local labelers/importers Relabel import from approved foreign manufacturers Often the “visible supplier” to pharmacies

Regulatory and labeling constraints that affect supply

Why cytotec supply can look fragmented

Cytotec distribution is affected by:

  • National marketing authorization and labeling requirements
  • Customs/import authorizations
  • Channel restrictions (some jurisdictions treat misoprostol use as sensitive)
  • Pharmacovigilance obligations tied to the MAH

These factors drive country-by-country differences in who is listed as supplier on the packaging and who can import or distribute it.


Actionable procurement checklist (supplier qualification)

What procurement should verify before sourcing Cytotec or misoprostol

  • Regulatory status: active marketing authorization in the destination country
  • Traceability: batch/lot information and ability to provide CoA
  • Quality alignment: impurity profile compliance with local standards
  • Supply continuity: production lead time and safety-stock terms
  • Distribution compliance: GDP-compliant handling requirements

Key Takeaways

  1. “Cytotec suppliers” are not one universal global list; the supplier depends on the country’s MAH and local importer/distributor.
  2. Supply typically splits into branded Cytotec distribution and widespread misoprostol generic manufacturing.
  3. The fastest way to map the real supplier for a purchase decision is to use the supplier/MAH/manufacturer/importer addresses shown on the labeled pack for that specific market.
  4. Procurement effectiveness depends on regulatory authorization, traceability, CoA, and GDP-compliant distribution, not just the brand name.

FAQs

Who is the supplier of Cytotec in a given country?

The supplier is the party listed on the carton/blister as MAH, manufacturer, and/or local importer/distributor for that market.

Are Cytotec and misoprostol supplied by the same companies?

Branded Cytotec and generic misoprostol can overlap at the API or contract manufacturing level, but the visible supplier to pharmacies is often the MAH/importer/distributor for the labeled product in that country.

Can a wholesaler sell Cytotec without being the MAH?

Yes. Licensed wholesalers commonly distribute products they did not manufacture, as long as they carry authorized stock from approved sources.

Is misoprostol widely available as generics?

Yes. Misoprostol is commonly manufactured as generics under multiple local brands in many jurisdictions, which can reduce reliance on a branded-only supplier chain.

What documents should be requested to qualify a supplier?

At minimum: CoA, batch traceability, proof of active authorization in-country, and distribution compliance evidence (GDP handling) for the channel.


References

  1. U.S. Food and Drug Administration (FDA). Misoprostol (Cytotec) label and related regulatory information.
  2. World Health Organization (WHO). Misoprostol monographs and related essential medicines information.
  3. European Medicines Agency (EMA). Product information and public assessment documents for misoprostol-containing medicines.

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