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...DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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*...DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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