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