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

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    Ganirelix Acetate

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    01 Anyzen Co., Ltd. (1)

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    Anygen

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      Ganirelix Acetate

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      Anyzen Co., Ltd.
      2023-10-20
      20231020-210-J-1554
      Anyzen Co., Ltd.
      South Korea
      773, Jeongjeongyeonje-ro,...
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      Looking for 129311-55-3 / Ganirelix API manufacturers, exporters & distributors?

      Ganirelix manufacturers, exporters & distributors 1

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

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

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

      API | Excipient name

      Ganirelix

      Synonyms

      129311-55-3, Ganirelix acetate [usan], Ganirelix acetate injection, Antagon, 56u7906fqw, Orgalutran

      Cas Number

      129311-55-3

      Unique Ingredient Identifier (UNII)

      56U7906FQW

      About Ganirelix

      Ganirelix Acetate is the acetate salt form of ganirelix, a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix directly competes with the GnRH for receptor binding in the anterior pituitary gland, thus induces a rapid and reversible suppression of the release of follicle stimulating hormone (FSH) and luteinizing hormone (LH). This agent is used for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation, and in combination with other hormones for retrieval of the mature follicles for in-vitro fertilization.

      Ganirelix Acetate Manufacturers

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

      Ganirelix Acetate Suppliers

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

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

      Ganirelix Acetate KDMF

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

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

      After submitting a Ganirelix Acetate 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 Ganirelix Acetate API can apply through the Korea Drug Master File (KDMF).

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

      Ganirelix Acetate Manufacturers | Traders | Suppliers

      Ganirelix Acetate Manufacturers, Traders, Suppliers 1
      56

      We have 1 companies offering Ganirelix Acetate

      Get in contact with the supplier of your choice:

      1. Anygen
      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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