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DOSAGE - IMPLANT;IMPLANTATION - EQ 3.6MG BASE
USFDA APPLICATION NUMBER - 19726
DOSAGE - IMPLANT;IMPLANTATION - EQ 10.8MG BAS...DOSAGE - IMPLANT;IMPLANTATION - EQ 10.8MG BASE
USFDA APPLICATION NUMBER - 20578
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PharmaCompass offers a list of Goserelin Acetate 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 Goserelin Acetate manufacturer or Goserelin Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Goserelin Acetate manufacturer or Goserelin Acetate supplier.
PharmaCompass also assists you with knowing the Goserelin Acetate API Price utilized in the formulation of products. Goserelin Acetate API Price is not always fixed or binding as the Goserelin Acetate Price is obtained through a variety of data sources. The Goserelin Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Goserelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Goserelin, including repackagers and relabelers. The FDA regulates Goserelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Goserelin 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 Goserelin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Goserelin supplier is an individual or a company that provides Goserelin active pharmaceutical ingredient (API) or Goserelin finished formulations upon request. The Goserelin suppliers may include Goserelin API manufacturers, exporters, distributors and traders.
click here to find a list of Goserelin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Goserelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Goserelin active pharmaceutical ingredient (API) in detail. Different forms of Goserelin DMFs exist exist since differing nations have different regulations, such as Goserelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Goserelin DMF submitted to regulatory agencies in the US is known as a USDMF. Goserelin USDMF includes data on Goserelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Goserelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Goserelin suppliers with USDMF on PharmaCompass.
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 Goserelin Drug Master File in Japan (Goserelin JDMF) empowers Goserelin 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 Goserelin JDMF during the approval evaluation for pharmaceutical products. At the time of Goserelin 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 Goserelin suppliers with JDMF on PharmaCompass.
A Goserelin CEP of the European Pharmacopoeia monograph is often referred to as a Goserelin Certificate of Suitability (COS). The purpose of a Goserelin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Goserelin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Goserelin to their clients by showing that a Goserelin CEP has been issued for it. The manufacturer submits a Goserelin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Goserelin CEP holder for the record. Additionally, the data presented in the Goserelin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Goserelin DMF.
A Goserelin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Goserelin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Goserelin suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Goserelin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Goserelin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Goserelin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Goserelin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Goserelin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Goserelin suppliers with NDC on PharmaCompass.
Goserelin 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 Goserelin 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 Goserelin GMP manufacturer or Goserelin GMP API supplier for your needs.
A Goserelin CoA (Certificate of Analysis) is a formal document that attests to Goserelin's compliance with Goserelin specifications and serves as a tool for batch-level quality control.
Goserelin CoA mostly includes findings from lab analyses of a specific batch. For each Goserelin 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.
Goserelin may be tested according to a variety of international standards, such as European Pharmacopoeia (Goserelin EP), Goserelin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Goserelin USP).
