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    Omadacycline

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

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    Sichuan Kelun Pharmaceutical Co Ltd

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    USDMF

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    Sichuan Kelun Pharmaceutical Co Ltd

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 41641

    Submission : 2025-03-26

    Status : Active

    Type : II

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    Looking for 389139-89-3 / Omadacycline API manufacturers, exporters & distributors?

    Omadacycline manufacturers, exporters & distributors 1

    72

    PharmaCompass offers a list of Omadacycline 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 Omadacycline manufacturer or Omadacycline supplier for your needs.

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

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

    API | Excipient name

    Omadacycline

    Synonyms

    Amadacycline, 389139-89-3, Nuzyra, Ptk 0796, Omadacycline [usan], Ptk-0796

    Cas Number

    389139-89-3

    Unique Ingredient Identifier (UNII)

    090IP5RV8F

    About Omadacycline

    Omadacycline has been used in trials studying the treatment of Bacterial Pneumonia, Bacterial Infections, Community-Acquired Infections, and Skin Structures and Soft Tissue Infections. Omadacycline represents a significant advance over the well-known tetracycline family, and has been shown to be highly effective in animal models at treating increasingly problematic, clinically prevalent infections caused by gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), and by gram-negative, atypical and anaerobic bacteria, including those resistant to currently available classes of antibiotics and known to cause diseases such as pneumonias, urinary tract infections, skin diseases and blood-borne infections in both the hospital and community settings.

    Omadacycline Manufacturers

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

    click here to find a list of Omadacycline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Omadacycline Suppliers

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

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

    Omadacycline USDMF

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

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

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

    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.