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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Drugs in Development
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DOSAGE - POWDER;INTRAMUSCULAR - 11.25MG
USFDA APPLICATION NUMBER - 20263
DOSAGE - POWDER;INTRAMUSCULAR - 15MG
USFDA APPLICATION NUMBER - 20263
DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG ...DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20263
DOSAGE - POWDER;INTRAMUSCULAR - 30MG
USFDA APPLICATION NUMBER - 20263
DOSAGE - POWDER;INTRAMUSCULAR - 45MG
USFDA APPLICATION NUMBER - 20263
DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG
USFDA APPLICATION NUMBER - 20263
DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG,7.5MG *...DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20263
DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
USFDA APPLICATION NUMBER - 203696
DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG
USFDA APPLICATION NUMBER - 203696
Related Excipient Companies
Nanjing Well Pharmaceutical
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USP
ABOUT THIS PAGE
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PharmaCompass offers a list of Leuprolide 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 Leuprolide Acetate manufacturer or Leuprolide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Leuprolide Acetate manufacturer or Leuprolide Acetate supplier.
PharmaCompass also assists you with knowing the Leuprolide Acetate API Price utilized in the formulation of products. Leuprolide Acetate API Price is not always fixed or binding as the Leuprolide Acetate Price is obtained through a variety of data sources. The Leuprolide Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Enantone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enantone, including repackagers and relabelers. The FDA regulates Enantone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enantone 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 Enantone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Enantone supplier is an individual or a company that provides Enantone active pharmaceutical ingredient (API) or Enantone finished formulations upon request. The Enantone suppliers may include Enantone API manufacturers, exporters, distributors and traders.
click here to find a list of Enantone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Enantone DMF (Drug Master File) is a document detailing the whole manufacturing process of Enantone active pharmaceutical ingredient (API) in detail. Different forms of Enantone DMFs exist exist since differing nations have different regulations, such as Enantone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enantone DMF submitted to regulatory agencies in the US is known as a USDMF. Enantone USDMF includes data on Enantone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enantone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Enantone 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 Enantone Drug Master File in Japan (Enantone JDMF) empowers Enantone 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 Enantone JDMF during the approval evaluation for pharmaceutical products. At the time of Enantone 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 Enantone 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 Enantone Drug Master File in Korea (Enantone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Enantone. The MFDS reviews the Enantone KDMF as part of the drug registration process and uses the information provided in the Enantone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Enantone 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 Enantone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Enantone suppliers with KDMF on PharmaCompass.
A Enantone CEP of the European Pharmacopoeia monograph is often referred to as a Enantone Certificate of Suitability (COS). The purpose of a Enantone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Enantone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Enantone to their clients by showing that a Enantone CEP has been issued for it. The manufacturer submits a Enantone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Enantone CEP holder for the record. Additionally, the data presented in the Enantone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Enantone DMF.
A Enantone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Enantone 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 Enantone suppliers with CEP (COS) on PharmaCompass.
A Enantone written confirmation (Enantone WC) is an official document issued by a regulatory agency to a Enantone manufacturer, verifying that the manufacturing facility of a Enantone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Enantone APIs or Enantone finished pharmaceutical products to another nation, regulatory agencies frequently require a Enantone WC (written confirmation) as part of the regulatory process.
click here to find a list of Enantone 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 Enantone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Enantone 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 Enantone 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 Enantone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Enantone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Enantone suppliers with NDC on PharmaCompass.
Enantone 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 Enantone 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 Enantone GMP manufacturer or Enantone GMP API supplier for your needs.
A Enantone CoA (Certificate of Analysis) is a formal document that attests to Enantone's compliance with Enantone specifications and serves as a tool for batch-level quality control.
Enantone CoA mostly includes findings from lab analyses of a specific batch. For each Enantone 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.
Enantone may be tested according to a variety of international standards, such as European Pharmacopoeia (Enantone EP), Enantone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Enantone USP).
