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...DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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*...DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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