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

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    Risdiplam

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    ALP PHARM BEIJING CO LTD

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      RISDIPLAM

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      2022-04-07
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      Looking for 1825352-65-5 / Risdiplam API manufacturers, exporters & distributors?

      Risdiplam manufacturers, exporters & distributors 1

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

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

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

      API | Excipient name

      Risdiplam

      Synonyms

      1825352-65-5, Rg7916, Evrysdi, Ro7034067, Risdiplam [inn], Risdiplam [usan]

      Cas Number

      1825352-65-5

      Unique Ingredient Identifier (UNII)

      76RS4S2ET1

      About Risdiplam

      Risdiplam is an orally bioavailable mRNA splicing modifier used for the treatment of spinal muscular atrophy (SMA). It increases systemic SMN protein concentrations by improving the efficiency of SMN2 gene transcription. This mechanism of action is similar to its predecessor [nusinersen], the biggest difference being their route of administration: nusinersen requires intrathecal administration, as does the one-time gene therapy [onasemnogene abeparvovec], whereas risdiplam offers the ease of oral bioavailability. Risdiplam was approved by the FDA in August 2020 for use in patients 2 months of age or older in the treatment of spinal muscular atrophy (SMA). Set to be substantially cheaper than other available SMA therapies, risdiplam appears to provide a novel and relatively accessible treatment option for patients with SMA regardless of severity or type.

      Risdiplam Manufacturers

      A Risdiplam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Risdiplam, including repackagers and relabelers. The FDA regulates Risdiplam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Risdiplam 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 Risdiplam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

      Risdiplam Suppliers

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

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

      Risdiplam USDMF

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

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

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

      Risdiplam Manufacturers | Traders | Suppliers

      Risdiplam Manufacturers, Traders, Suppliers 1
      11

      We have 1 companies offering Risdiplam

      Get in contact with the supplier of your choice:

      1. ALP Pharm
      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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