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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Certificate Number : R1-CEP 2001-454 - Rev 01
Status : Valid
Issue Date : 2009-02-18
Type : Chemical
Substance Number : 1442
Aspen API. More than just an API™
Certificate Number : R1-CEP 2016-199 - Rev 00
Status : Valid
Issue Date : 2022-08-26
Type : Chemical
Substance Number : 1442
Aspen API. More than just an API™
Certificate Number : R0-CEP 2021-472 - Rev 00
Status : Valid
Issue Date : 2022-02-28
Type : Chemical
Substance Number : 1442
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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...DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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*...DOSAGE - POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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US Patents
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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, 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.
A Lupron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lupron, including repackagers and relabelers. The FDA regulates Lupron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lupron 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 Lupron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lupron supplier is an individual or a company that provides Lupron active pharmaceutical ingredient (API) or Lupron finished formulations upon request. The Lupron suppliers may include Lupron API manufacturers, exporters, distributors and traders.
click here to find a list of Lupron suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lupron DMF (Drug Master File) is a document detailing the whole manufacturing process of Lupron active pharmaceutical ingredient (API) in detail. Different forms of Lupron DMFs exist exist since differing nations have different regulations, such as Lupron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lupron DMF submitted to regulatory agencies in the US is known as a USDMF. Lupron USDMF includes data on Lupron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lupron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lupron 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 Lupron Drug Master File in Japan (Lupron JDMF) empowers Lupron 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 Lupron JDMF during the approval evaluation for pharmaceutical products. At the time of Lupron 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 Lupron 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 Lupron Drug Master File in Korea (Lupron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lupron. The MFDS reviews the Lupron KDMF as part of the drug registration process and uses the information provided in the Lupron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lupron 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 Lupron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lupron suppliers with KDMF on PharmaCompass.
A Lupron CEP of the European Pharmacopoeia monograph is often referred to as a Lupron Certificate of Suitability (COS). The purpose of a Lupron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lupron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lupron to their clients by showing that a Lupron CEP has been issued for it. The manufacturer submits a Lupron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lupron CEP holder for the record. Additionally, the data presented in the Lupron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lupron DMF.
A Lupron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lupron 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 Lupron suppliers with CEP (COS) on PharmaCompass.
A Lupron written confirmation (Lupron WC) is an official document issued by a regulatory agency to a Lupron manufacturer, verifying that the manufacturing facility of a Lupron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lupron APIs or Lupron finished pharmaceutical products to another nation, regulatory agencies frequently require a Lupron WC (written confirmation) as part of the regulatory process.
click here to find a list of Lupron 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 Lupron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lupron 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 Lupron 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 Lupron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lupron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lupron suppliers with NDC on PharmaCompass.
Lupron 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 Lupron GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Lupron GMP manufacturer or Lupron GMP API supplier for your needs.
A Lupron CoA (Certificate of Analysis) is a formal document that attests to Lupron's compliance with Lupron specifications and serves as a tool for batch-level quality control.
Lupron CoA mostly includes findings from lab analyses of a specific batch. For each Lupron 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.
Lupron may be tested according to a variety of international standards, such as European Pharmacopoeia (Lupron EP), Lupron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lupron USP).
