Sinapultide

CAS 138531-07-4 1 current record 2 historicalProtein

Who holds supplier records for Sinapultide? 1 organisation holds a current record for Sinapultide: an active US FDA Type II Drug Master File. A further 2 organisations have only historical (inactive) DMF filings. Recorded organisation countries for current records: China (1).

Sources: FDA Drug Master File list, EDQM certification database, FDA Orange Book. Record updated 3 Aug 2026. How we read these records

Reading the evidence

  • One current record

    One organisation holds a current DMF or CEP. A record shows a regulatory filing, not current commercial availability or a qualified source for your product.

  • No company-level GMP certificate matched

    No current EU or UK GMP certificate was matched to these organisations. That is not a negative finding; ask each candidate for its certificate and latest inspection outcome.

Current records (1)

Organisations holding an active US FDA Type II Drug Master File or a CEP for Sinapultide. Country is the organisation's recorded country, not necessarily the manufacturing site.

China1
  • Porton Pharma (Shanghai) Co., Ltd.
    Active DMF 44178 · latest filing May 2026
    China
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Historical records (2)

Organisations whose Type II DMFs for Sinapultide are no longer active. These show a past filing, not current supply.

Show all 2 historical records
  • POLYPEPTIDE LABS INC
    Inactive DMF 16615 · filed May 2003
  • BACHEM AMERICAS INC
    Inactive DMF 12701 · filed Oct 1997

Overview

Sinapultide is a protein active pharmaceutical ingredient (ChEMBL CHEMBL2103901).

Chemical identity

IUPAC name
(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2,6-diaminohexanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]hexanoic acid
Canonical SMILES
CC(C)C[C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)O)NC(=O)[C@H](CCCCN)N
InChIKey
QSIRXSYRKZHJHX-TWXHAJHVSA-N
Synonyms
ATI 01, ATI-01, KL-4, KL4, Kl4 peptide, PEPTIDE KL-4, PEPTIDE KL4, RWJ-45652, Sinapultida, Sinapultide, Sinapultidum, RefChem:183150

Record history

PharmaTek records which organisations hold a current DMF or CEP for Sinapultide every week, starting 23 Oct 2026. Additions and lapses will appear here from the next weekly release.

Monitoring pilot: get an email when these records change. Places are confirmed by a person; nothing is sent until then. All changes this week

What these records establish

  • An active DMF means a confidential file is held by the FDA and can be referenced; the FDA does not approve or disapprove DMFs.
  • A CEP confirms monograph suitability for the EU market; it is not a GMP certificate, and the holder may not be the manufacturer.
  • Historical records show a past filing, not current supply.
  • Company GMP certificates are matched to the organisation, not to the site making this substance.
  • A substance missing from these registers is not evidence that no supplier exists.

Frequently asked questions

Which organisations hold current supplier records for Sinapultide?

1 organisation holds an active US FDA Type II Drug Master File or a CEP for Sinapultide: Porton Pharma (Shanghai) Co., Ltd. (China). A DMF or CEP shows a regulatory filing, not current commercial availability, and the holder is not necessarily the manufacturing site.

Which Sinapultide Drug Master Files are active?

Porton Pharma (Shanghai) Co., Ltd. (DMF 44178). The FDA does not approve or disapprove DMFs; an active DMF can be referenced in an application once its holder issues a letter of authorisation.

What do the historical Sinapultide records mean?

2 organisations have only inactive Type II DMFs for Sinapultide. An inactive DMF records that a filing once existed; it does not show that the organisation supplies the substance today.

How do I qualify a Sinapultide supplier?

Confirm the DMF or CEP is current and covers your grade, obtain the letter of authorisation, identify the actual manufacturing site and check its GMP certificate and FDA inspection history, audit the site or review a recent audit, and run comparable requests for information across more than one candidate.

For suppliers

Do you supply Sinapultide?

Send a link to a certificate, registration or filing we have missed or got wrong. We check it against the issuing register before changing anything; information we cannot check against a register is shown as supplier-reported.

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