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

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HYDRO MED SCIENCES

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1992-09-29
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Looking for 76712-82-8 / Histrelin API manufacturers, exporters & distributors?

Histrelin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Histrelin

Synonyms

76712-82-8, Histrelin acetate, Histrelinum, Orf 17070, Rwj 17070, Histrelina

Cas Number

76712-82-8

Unique Ingredient Identifier (UNII)

H50H3S3W74

About Histrelin

Histrelin is a long-acting, synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH) with potential anti-tumor activity. Upon administration, histrelin binds to and activates GnRH receptors; prolonged administration results in pituitary GnRH receptor desensitization and inhibition of follicle stimulating hormone (FSH) and luteinizing hormone (LH) secretion, leading to a significant decline in testosterone production in males and may inhibit androgen receptor-positive tumor progression; in females, prolonged administration results in decreased estradiol production.

Histrelin Manufacturers

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

Histrelin Suppliers

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

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

Histrelin USDMF

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

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

click here to find a list of Histrelin 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.
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