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    List of Drug Master Files (DMF) of Sinapultide Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Sinapultide

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    01 PolyPeptide Group (1)

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    01 KL4 ACETATE (SINAPULTIDE) (1)

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    POLYPEPTIDE LABS INC

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    KL4 ACETATE (SINAPULTIDE)

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    2003-05-30
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    Looking for 138531-07-4 / Sinapultide API manufacturers, exporters & distributors?

    Sinapultide manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Sinapultide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sinapultide manufacturer or Sinapultide supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sinapultide manufacturer or Sinapultide supplier.

    PharmaCompass also assists you with knowing the Sinapultide API Price utilized in the formulation of products. Sinapultide API Price is not always fixed or binding as the Sinapultide Price is obtained through a variety of data sources. The Sinapultide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Sinapultide

    Synonyms

    138531-07-4, Ati 01, Kl4 (peptide), Sinapultide [usan:inn], Unii-040x3ax99t, Kl4 peptide

    Cas Number

    138531-07-4

    About Sinapultide

    Sinapultide (also known as KL4 peptide) is a synthetic protein used to mimic human lung surfactant protein B. This protein has a weight of 2469.40. Sinapultide is a 21-residue peptide made up of lysine (K) and leucine (L) residues with the sequence KLLLLKLLLLKLLLLKLLLLK (KL4), in aqueous dispersion with the phospholipids DPPC (dipalmitoylphosphatidylcholine), POPG (palmitoyloleoyl-phosphatidylglycerol), and palmitic acid, to create the drug [lucinactant]. The product was originally developed by the Scripps Research Institute, then licensed to Windtree Therapeutics. Windtree Therapeutics plans a phase III trial for Respiratory distress syndrome in 2018. Respiratory distress syndrome (RDS) is a major cause of mortality and morbidity in preterm infants. Surfactant replacement therapy has been commonly used to prevent and treat RDS in these newborns and is now a standard of care. First-generation synthetic surfactants that were previously used, such as Exosurf did not contain any surfactant protein. This large disadvantage was overcome with animal-derived surfactant products which contain specific proteins but are limited, but must be derived from animal sources. This has led to the development of newer synthetic surfactants such as lucinactant (Surfaxin), which contains sinapultide. Phase 3 clinical trials with Surfaxin show promising results with similar efficacy as animal-derived surfactants while avoiding the use of animal-origin products. Windtree is currently developing aerosolized KL4 surfactant to treat RDS in premature infants, and thereafter, to potentially address a range of indications in neonatal, pediatric and adult critical care patient populations.

    Sinapultide Manufacturers

    A Sinapultide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sinapultide, including repackagers and relabelers. The FDA regulates Sinapultide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sinapultide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    Sinapultide Suppliers

    A Sinapultide supplier is an individual or a company that provides Sinapultide active pharmaceutical ingredient (API) or Sinapultide finished formulations upon request. The Sinapultide suppliers may include Sinapultide API manufacturers, exporters, distributors and traders.

    click here to find a list of Sinapultide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Sinapultide USDMF

    A Sinapultide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sinapultide active pharmaceutical ingredient (API) in detail. Different forms of Sinapultide DMFs exist exist since differing nations have different regulations, such as Sinapultide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Sinapultide DMF submitted to regulatory agencies in the US is known as a USDMF. Sinapultide USDMF includes data on Sinapultide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sinapultide USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Sinapultide suppliers with USDMF on PharmaCompass.

    Sinapultide Manufacturers | Traders | Suppliers

    Sinapultide Manufacturers, Traders, Suppliers 1
    21

    We have 1 companies offering Sinapultide

    Get in contact with the supplier of your choice:

    1. PolyPeptide Group
    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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