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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Aspen API. More than just an API.
CEP/COS
NDC
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
CEP/COS
NDC
KDMF
VMF
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Aspen API. More than just an API.
NDC
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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ABOUT THIS PAGE
A Gonadorelin Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gonadorelin Acetate, including repackagers and relabelers. The FDA regulates Gonadorelin Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gonadorelin 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 Gonadorelin Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gonadorelin Acetate supplier is an individual or a company that provides Gonadorelin Acetate active pharmaceutical ingredient (API) or Gonadorelin Acetate finished formulations upon request. The Gonadorelin Acetate suppliers may include Gonadorelin Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Gonadorelin Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gonadorelin Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Gonadorelin Acetate active pharmaceutical ingredient (API) in detail. Different forms of Gonadorelin Acetate DMFs exist exist since differing nations have different regulations, such as Gonadorelin Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gonadorelin Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Gonadorelin Acetate USDMF includes data on Gonadorelin Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gonadorelin Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gonadorelin Acetate 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 Gonadorelin Acetate Drug Master File in Japan (Gonadorelin Acetate JDMF) empowers Gonadorelin 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 Gonadorelin Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Gonadorelin 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 Gonadorelin Acetate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Gonadorelin Acetate Drug Master File in Korea (Gonadorelin Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gonadorelin Acetate. The MFDS reviews the Gonadorelin Acetate KDMF as part of the drug registration process and uses the information provided in the Gonadorelin Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gonadorelin 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 Gonadorelin Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gonadorelin Acetate suppliers with KDMF on PharmaCompass.
A Gonadorelin Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Gonadorelin Acetate Certificate of Suitability (COS). The purpose of a Gonadorelin Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gonadorelin Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gonadorelin Acetate to their clients by showing that a Gonadorelin Acetate CEP has been issued for it. The manufacturer submits a Gonadorelin Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gonadorelin Acetate CEP holder for the record. Additionally, the data presented in the Gonadorelin Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gonadorelin Acetate DMF.
A Gonadorelin Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gonadorelin Acetate 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 Gonadorelin Acetate suppliers with CEP (COS) on PharmaCompass.
A Gonadorelin Acetate written confirmation (Gonadorelin Acetate WC) is an official document issued by a regulatory agency to a Gonadorelin Acetate manufacturer, verifying that the manufacturing facility of a Gonadorelin Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gonadorelin Acetate APIs or Gonadorelin Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Gonadorelin Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Gonadorelin Acetate suppliers with Written Confirmation (WC) 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 Gonadorelin Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gonadorelin Acetate 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 Gonadorelin Acetate 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 Gonadorelin Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gonadorelin Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gonadorelin Acetate suppliers with NDC on PharmaCompass.
Gonadorelin Acetate 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 Gonadorelin Acetate 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 Gonadorelin Acetate GMP manufacturer or Gonadorelin Acetate GMP API supplier for your needs.
A Gonadorelin Acetate CoA (Certificate of Analysis) is a formal document that attests to Gonadorelin Acetate's compliance with Gonadorelin Acetate specifications and serves as a tool for batch-level quality control.
Gonadorelin Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Gonadorelin Acetate 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.
Gonadorelin Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Gonadorelin Acetate EP), Gonadorelin Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gonadorelin Acetate USP).
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