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    List of Drug Master Files (KDMF) for Selexipag Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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    Selexipag

    APIs // Active Pharmaceutical Ingredients

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    Maithili Life Sciences

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      Selexipag

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      Aging Life Science Co., Ltd.
      2021-12-23
      20211223-211-J-1181
      Maithri Drugs Private Lim...
      India
      Sy. No. 205, 222 to 226, ...
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      Looking for 475086-01-2 / Selexipag API manufacturers, exporters & distributors?

      Selexipag manufacturers, exporters & distributors 1

      91

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

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

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

      API | Excipient name

      Selexipag

      Synonyms

      475086-01-2, Ns-304, Uptravi, Act-293987, Ns 304, Act 293987

      Cas Number

      475086-01-2

      Unique Ingredient Identifier (UNII)

      5EXC0E384L

      About Selexipag

      Selexipag was approved by the United States FDA on December 22, 2015 for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce risk of hospitalization. PAH is a relatively rare disease with usually a poor prognosis requiring more treatment options to prolong long-term outcomes. Marketed by Actelion Pharmaceuticals under brand name Uptravi, selexipag and its active metabolite, ACT-333679 (MRE-269), act as agonists of the prostacyclin receptor to increase vasodilation in the pulmonary circulation and decrease elevated pressure in the blood vessels supplying blood to the lungs.

      Selexipag Manufacturers

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

      Selexipag Suppliers

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

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

      Selexipag KDMF

      In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

      Pharmaceutical companies submit a Selexipag Drug Master File in Korea (Selexipag KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Selexipag. The MFDS reviews the Selexipag KDMF as part of the drug registration process and uses the information provided in the Selexipag KDMF to evaluate the safety and efficacy of the drug.

      After submitting a Selexipag KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Selexipag API can apply through the Korea Drug Master File (KDMF).

      click here to find a list of Selexipag suppliers with KDMF on PharmaCompass.

      Selexipag Manufacturers | Traders | Suppliers

      Selexipag Manufacturers, Traders, Suppliers 1
      67

      We have 1 companies offering Selexipag

      Get in contact with the supplier of your choice:

      1. Maithili Life Sciences
      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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