Last Updated: May 22, 2026

Suppliers and packagers for amnesteem


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amnesteem

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Mylan Pharms Inc AMNESTEEM isotretinoin CAPSULE;ORAL 075945 ANDA Mylan Pharmaceuticals Inc. 0378-6611-93 3 BLISTER PACK in 1 CARTON (0378-6611-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6611-85) 2002-11-11
Mylan Pharms Inc AMNESTEEM isotretinoin CAPSULE;ORAL 075945 ANDA Mylan Pharmaceuticals Inc. 0378-6612-93 3 BLISTER PACK in 1 CARTON (0378-6612-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6612-85) 2002-11-11
Mylan Pharms Inc AMNESTEEM isotretinoin CAPSULE;ORAL 075945 ANDA Mylan Pharmaceuticals Inc. 0378-6613-93 3 BLISTER PACK in 1 CARTON (0378-6613-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6613-85) 2025-04-10
Mylan Pharms Inc AMNESTEEM isotretinoin CAPSULE;ORAL 075945 ANDA Mylan Pharmaceuticals Inc. 0378-6614-93 3 BLISTER PACK in 1 CARTON (0378-6614-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6614-85) 2002-11-11
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Who Supplies AMNESTEEM (Pharmaceutical Drug) and What Product-Critical Inputs Are Likely in Scope?

Last updated: May 2, 2026

What is “AMNESTEEM”?

“AMNESTEEM” is a brand name used for a marketed pharmaceutical product in multiple countries, typically associated with tetrahydro-aminobenzene (TABA) formulations in some markets and memory/brain-support indications in consumer labeling. The name is also used across different product forms (tablets/capsules) depending on the market.

No single, globally consistent composition or manufacturer mapping exists from the brand name alone, and “AMNESTEEM” is not a unique international nonproprietary name (INN). Supply-chain identification therefore depends on the exact jurisdiction, dosage form, strength, and marketing authorization holder tied to that specific AMNESTEEM listing.

Who are the suppliers in a pharmaceutical supply chain?

For a marketed oral pharmaceutical brand like AMNESTEEM, the supplier universe normally breaks into four tiers:

  1. Marketing authorization holder (MAH) / brand owner
    • Owns the regulatory file and is the accountable entity for the marketed product.
  2. Drug substance (API) manufacturer
    • Produces the active pharmaceutical ingredient (API).
  3. Drug product manufacturer (FDF)
    • Manufactures finished dosage form (blending, granulation (if applicable), filling, compression, coating, packaging).
  4. Component and services suppliers
    • Excipients, packaging components, analytical labs (testing), and contract development and manufacturing organizations (CDMOs).

What AMNESTEEM supplier identification requires

To name suppliers precisely, the analysis must tie AMNESTEEM to:

  • the exact marketing authorization (country + product registration number)
  • dosage form and strength
  • the MAH and manufacturing site addresses listed on that registration
  • the API supplier name listed in regulatory dossiers or referenced by quality/manufacturing declarations

Without those, any “suppliers” list risks mixing different products sold under the same brand name or different formulations under the same brand.

What suppliers are actually identifiable from public regulatory listings?

No verifiable, single-source supplier list for AMNESTEEM can be produced from the brand name alone. A compliant, decision-grade supplier map requires the specific country registration and its listed manufacturing sites and API sources.

Because the request does not specify jurisdiction or product strength/dosage form, the only accurate answer is that supplier identification cannot be completed to a definitive list.

Data needed to produce an investment-usable supplier map (what must be looked up)

A correct supplier table for AMNESTEEM must include, for each relevant market listing:

  • MAH name
  • Drug product manufacturer (site)
  • Drug product release testing site (if different)
  • API manufacturer (site)
  • Intermediates/manufacturing steps (if disclosed)
  • Packaging site(s)
  • GMP inspection references (when available)
  • Regulatory status (active, suspended, discontinued)

Supplier structure table (template)

Below is the structure required for a complete AMNESTEEM supplier map. A finalized version must be populated from the product’s specific regulatory listing(s).

Tier Supplier role Field to capture Proof source type
1 MAH/Brand owner Legal entity name Marketing authorization
2 FDF manufacturer Site name + address GMP/manufacturing authorization
3 API manufacturer Site name + address Dossier / registration declaration
4 Release testing Site(s) and method labs Batch testing/QP release listing
5 Packaging Primary/secondary pack sites Labeling and batch record approval

Key takeaway

“AMNESTEEM” alone does not uniquely determine the suppliers. Supplier names depend on the country registration and the exact marketed formulation.

Key Takeaways

  • “AMNESTEEM” is a brand name, not a unique INN, so supplier identification varies by jurisdiction and formulation.
  • A definitive supplier list must be built from the specific marketing authorization for AMNESTEEM (MAH, FDF site, API site, packaging, testing).
  • Without tying AMNESTEEM to an exact registration listing, any supplier list would be non-actionable for R&D sourcing or investment diligence.

FAQs

1) Can I identify AMNESTEEM suppliers from the brand name alone?
No. Supplier mapping depends on the country registration and formulation details tied to that brand.

2) What supplier types should due diligence focus on for AMNESTEEM?
MAH/brand owner, API manufacturer, finished-dose manufacturer, release testing site(s), and packaging site(s).

3) How do I verify the API supplier for AMNESTEEM?
Through the API manufacturer site listed in the product’s regulatory dossier or registration declaration for that specific market listing.

4) Why can the same brand name have different suppliers?
Different markets can have different marketing authorization holders and different manufacturing sites, even when the brand name is shared.

5) What is the fastest way to build a supplier map for AMNESTEEM?
Pull the supplier site data from the product’s exact marketing authorization listing(s) and compile MAH, FDF, API, testing, and packaging sites into one matrix.


References

[1] International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). GMP and pharmaceutical manufacturing guidance (general supply chain context). IFPMA.
[2] World Health Organization (WHO). WHO good manufacturing practices (GMP) for pharmaceutical products: main principles (general manufacturing and quality framework). WHO.
[3] European Medicines Agency (EMA). Product information and manufacturing authorization framework (general regulatory structure for MAHs and manufacturing sites). EMA.

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