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List of Japan Drug Master File (JDMF) for Ganirelix Acetate Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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230MF10067
Hybio Medicine Park, No. 37, Keji C...
2018-05-31
2018-05-31
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2-1-3 Nihonbashi, Chuo-ku, Tokyo
2018-08-08
2018-08-08
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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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Ganirelix Acetate Drug Master File in Japan (Ganirelix Acetate JDMF) empowers Ganirelix Acetate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Ganirelix Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Ganirelix Acetate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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

Ganirelix Acetate Manufacturers | Traders | Suppliers

Ganirelix Acetate Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Ganirelix Acetate

Get in contact with the supplier of your choice:

  1. Hybio Pharmaceutical
  2. Sekisui Medical Co. Ltd
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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