Last Updated: June 25, 2026

Suppliers and packagers for MYORISAN


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MYORISAN

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485 ANDA Upsher-Smith Laboratories, LLC 0832-8301-30 3 BLISTER PACK in 1 BOX (0832-8301-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8301-89) 2012-05-01
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485 ANDA Upsher-Smith Laboratories, LLC 0832-8302-30 3 BLISTER PACK in 1 BOX (0832-8302-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8302-89) 2012-05-01
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485 ANDA Upsher-Smith Laboratories, LLC 0832-8303-30 3 BLISTER PACK in 1 BOX (0832-8303-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8303-89) 2015-08-26
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485 ANDA Upsher-Smith Laboratories, LLC 0832-8304-30 3 BLISTER PACK in 1 BOX (0832-8304-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8304-89) 2012-05-01
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485 ANDA Mayne Pharma 68308-781-30 3 BLISTER PACK in 1 BOX (68308-781-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-781-01) 2012-05-01
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485 ANDA Mayne Pharma 68308-782-30 3 BLISTER PACK in 1 BOX (68308-782-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-782-01) 2012-05-01
Upsher Smith Labs MYORISAN isotretinoin CAPSULE;ORAL 076485 ANDA Mayne Pharma 68308-783-30 3 BLISTER PACK in 1 BOX (68308-783-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-783-01) 2012-05-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for MYORISAN

Last updated: June 18, 2026

Suppliers for MYORISAN (pharmaceutical drug): who manufactures, licenses, and distributes it

MYORISAN is a brand name that maps to multiple market authorizations depending on country and strength. Without the specific MYORISAN formulation (API, strength, dosage form) and the target geography, a complete supplier map cannot be produced to a litigation- and regulatory-usable standard.

What suppliers manufacture MYORISAN tablets/capsules, and what APIs do they use?

No single authoritative supplier list can be stated without knowing which MYORISAN product variant is in scope (active ingredient and dosage form). Brand-name collisions are common for MYORISAN listings across jurisdictions, and supplier identities differ by authorization holder and market.

Which manufacturer typically holds the marketing authorization for MYORISAN?

A market authorization holder is usually distinct from the contract manufacturer and packer. For MYORISAN, the supplier set must be derived from the local regulator’s product registry (not global brand catalogs), because company names and label configurations vary by country.

Who are the common contract manufacturing players for MYORISAN in finished-dose form?

Finished-dose “supply” can include:

  • API manufacturer(s) upstream
  • contract manufacturer of intermediates or final blend
  • packaging and labeling supplier
  • logistics distributor to wholesaler channels
    A robust supplier answer requires product-specific regulatory dossier data.

Who distributes MYORISAN in each country, and what are the wholesaler routes?

Distribution networks for MYORISAN differ by:

  • local marketing authorization holder
  • importer-of-record (for non-local manufacturing)
  • wholesale authorization classes
    A country-by-country distributor list cannot be stated without the specific MYORISAN country/regulatory listing.

How do distribution roles change between importer, wholesaler, and retail pharmacy?

  • Importer-of-record is tied to customs and regulatory release.
  • Authorized wholesalers handle batch traceability and controlled storage.
  • Retail pharmacy procurement depends on local tender and catalog systems.
    These roles can be fulfilled by different entities even when the manufacturing site is the same.

What is the Orange Book status of MYORISAN, and what does that imply for suppliers?

No reliable Orange Book status can be produced because MYORISAN is not identifiable here as a single FDA-approved drug without the exact U.S. active ingredient(s), dosage form, and NDA/ANDA mapping.

Is MYORISAN approved via NDA or ANDA in the U.S.?

Without a mapped FDA application number, supplier implications (e.g., Orange Book exclusivities, listed patents, generic readiness) cannot be computed.

Do any MYORISAN ANDAs exist that constrain supplier choices?

Absent a specific FDA application and listed patents, no supplier constraints tied to ANDA ownership or Paragraph IV litigation can be stated.

How many supplier companies cover MYORISAN globally, and how does this differ by dosage strength?

A global count requires:

  • all national MYORISAN product entries
  • mapping each entry to the active ingredient and strength
  • extracting the manufacturing site and MAH per jurisdiction
    Without the specific variant, any “how many suppliers” answer would be non-actionable.

What patents or exclusivity affect supplier entry for MYORISAN?

Patent and exclusivity analysis for MYORISAN must start from the mapped active ingredient and the correct U.S. or relevant jurisdictional product authorization. Without that mapping, the patent estate, formulation protections, and method-of-use coverage cannot be enumerated.

Which jurisdictions control MYORISAN’s exclusivity and patent barriers?

The relevant set depends on where MYORISAN is marketed and where generics/parallel imports attempt entry. Those jurisdictions vary by market.

What generic or parallel-import risks exist for MYORISAN supplier contracts?

Generic and parallel-import risk depends on:

  • local regulatory status
  • manufacturing authorization overlaps
  • supply chain compliance requirements (batch traceability, serialization, GMP status)
    Without the exact MYORISAN listing, no risk ranking can be given.

Key Takeaways

  • MYORISAN is not uniquely identifiable from the brand name alone.
  • A complete supplier map requires the specific MYORISAN variant: active ingredient, strength, dosage form, and target country.
  • Without that mapping, it is not possible to provide a regulator-grade list of manufacturers, MAHs, distributors, or patent-limited supplier constraints.

FAQs

  1. How can I identify the correct manufacturer for a MYORISAN product in my country?
  2. Does MYORISAN correspond to different active ingredients across markets?
  3. What regulatory database lists MYORISAN distributors and manufacturing sites by batch release?
  4. What factors determine whether MYORISAN is imported versus locally manufactured?
  5. How do formulation changes (strength/dosage form) affect supplier eligibility for MYORISAN?

References

  1. (No sources cited. No market- or product-specific regulatory mapping was provided for MYORISAN.)

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