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PharmaCompass offers a list of Gonadorelin 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 Gonadorelin Acetate manufacturer or Gonadorelin Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gonadorelin Acetate manufacturer or Gonadorelin Acetate supplier.
PharmaCompass also assists you with knowing the Gonadorelin Acetate API Price utilized in the formulation of products. Gonadorelin Acetate API Price is not always fixed or binding as the Gonadorelin Acetate Price is obtained through a variety of data sources. The Gonadorelin Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gonadorelin Diacetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gonadorelin Diacetate, including repackagers and relabelers. The FDA regulates Gonadorelin Diacetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gonadorelin Diacetate 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 Diacetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gonadorelin Diacetate supplier is an individual or a company that provides Gonadorelin Diacetate active pharmaceutical ingredient (API) or Gonadorelin Diacetate finished formulations upon request. The Gonadorelin Diacetate suppliers may include Gonadorelin Diacetate API manufacturers, exporters, distributors and traders.
click here to find a list of Gonadorelin Diacetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gonadorelin Diacetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Gonadorelin Diacetate active pharmaceutical ingredient (API) in detail. Different forms of Gonadorelin Diacetate DMFs exist exist since differing nations have different regulations, such as Gonadorelin Diacetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gonadorelin Diacetate DMF submitted to regulatory agencies in the US is known as a USDMF. Gonadorelin Diacetate USDMF includes data on Gonadorelin Diacetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gonadorelin Diacetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gonadorelin Diacetate 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 Diacetate Drug Master File in Japan (Gonadorelin Diacetate JDMF) empowers Gonadorelin Diacetate 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 Diacetate JDMF during the approval evaluation for pharmaceutical products. At the time of Gonadorelin Diacetate 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 Diacetate 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 Diacetate Drug Master File in Korea (Gonadorelin Diacetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gonadorelin Diacetate. The MFDS reviews the Gonadorelin Diacetate KDMF as part of the drug registration process and uses the information provided in the Gonadorelin Diacetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gonadorelin Diacetate 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 Diacetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gonadorelin Diacetate suppliers with KDMF on PharmaCompass.
A Gonadorelin Diacetate CEP of the European Pharmacopoeia monograph is often referred to as a Gonadorelin Diacetate Certificate of Suitability (COS). The purpose of a Gonadorelin Diacetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gonadorelin Diacetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gonadorelin Diacetate to their clients by showing that a Gonadorelin Diacetate CEP has been issued for it. The manufacturer submits a Gonadorelin Diacetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gonadorelin Diacetate CEP holder for the record. Additionally, the data presented in the Gonadorelin Diacetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gonadorelin Diacetate DMF.
A Gonadorelin Diacetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gonadorelin Diacetate 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 Diacetate suppliers with CEP (COS) on PharmaCompass.
A Gonadorelin Diacetate written confirmation (Gonadorelin Diacetate WC) is an official document issued by a regulatory agency to a Gonadorelin Diacetate manufacturer, verifying that the manufacturing facility of a Gonadorelin Diacetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gonadorelin Diacetate APIs or Gonadorelin Diacetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Gonadorelin Diacetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Gonadorelin Diacetate 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 Diacetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gonadorelin Diacetate 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 Diacetate 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 Diacetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gonadorelin Diacetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gonadorelin Diacetate suppliers with NDC on PharmaCompass.
Gonadorelin Diacetate 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 Diacetate 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 Diacetate GMP manufacturer or Gonadorelin Diacetate GMP API supplier for your needs.
A Gonadorelin Diacetate CoA (Certificate of Analysis) is a formal document that attests to Gonadorelin Diacetate's compliance with Gonadorelin Diacetate specifications and serves as a tool for batch-level quality control.
Gonadorelin Diacetate CoA mostly includes findings from lab analyses of a specific batch. For each Gonadorelin Diacetate 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 Diacetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Gonadorelin Diacetate EP), Gonadorelin Diacetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gonadorelin Diacetate USP).
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