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