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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.
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.
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.
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.
Histrelin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Histrelin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Histrelin GMP manufacturer or Histrelin GMP API supplier for your needs.
A Histrelin CoA (Certificate of Analysis) is a formal document that attests to Histrelin's compliance with Histrelin specifications and serves as a tool for batch-level quality control.
Histrelin CoA mostly includes findings from lab analyses of a specific batch. For each Histrelin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Histrelin may be tested according to a variety of international standards, such as European Pharmacopoeia (Histrelin EP), Histrelin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Histrelin USP).