Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
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...DOSAGE - POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Topical
Solubilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
57
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 DEPOT-PED manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LUPRON DEPOT-PED, including repackagers and relabelers. The FDA regulates LUPRON DEPOT-PED manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LUPRON DEPOT-PED 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 DEPOT-PED manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A LUPRON DEPOT-PED supplier is an individual or a company that provides LUPRON DEPOT-PED active pharmaceutical ingredient (API) or LUPRON DEPOT-PED finished formulations upon request. The LUPRON DEPOT-PED suppliers may include LUPRON DEPOT-PED API manufacturers, exporters, distributors and traders.
click here to find a list of LUPRON DEPOT-PED suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A LUPRON DEPOT-PED DMF (Drug Master File) is a document detailing the whole manufacturing process of LUPRON DEPOT-PED active pharmaceutical ingredient (API) in detail. Different forms of LUPRON DEPOT-PED DMFs exist exist since differing nations have different regulations, such as LUPRON DEPOT-PED USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LUPRON DEPOT-PED DMF submitted to regulatory agencies in the US is known as a USDMF. LUPRON DEPOT-PED USDMF includes data on LUPRON DEPOT-PED's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LUPRON DEPOT-PED USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LUPRON DEPOT-PED 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 DEPOT-PED Drug Master File in Japan (LUPRON DEPOT-PED JDMF) empowers LUPRON DEPOT-PED 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 DEPOT-PED JDMF during the approval evaluation for pharmaceutical products. At the time of LUPRON DEPOT-PED 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 DEPOT-PED 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 DEPOT-PED Drug Master File in Korea (LUPRON DEPOT-PED KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LUPRON DEPOT-PED. The MFDS reviews the LUPRON DEPOT-PED KDMF as part of the drug registration process and uses the information provided in the LUPRON DEPOT-PED KDMF to evaluate the safety and efficacy of the drug.
After submitting a LUPRON DEPOT-PED 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 DEPOT-PED API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LUPRON DEPOT-PED suppliers with KDMF on PharmaCompass.
A LUPRON DEPOT-PED CEP of the European Pharmacopoeia monograph is often referred to as a LUPRON DEPOT-PED Certificate of Suitability (COS). The purpose of a LUPRON DEPOT-PED CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LUPRON DEPOT-PED EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LUPRON DEPOT-PED to their clients by showing that a LUPRON DEPOT-PED CEP has been issued for it. The manufacturer submits a LUPRON DEPOT-PED CEP (COS) as part of the market authorization procedure, and it takes on the role of a LUPRON DEPOT-PED CEP holder for the record. Additionally, the data presented in the LUPRON DEPOT-PED CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LUPRON DEPOT-PED DMF.
A LUPRON DEPOT-PED CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LUPRON DEPOT-PED 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 DEPOT-PED suppliers with CEP (COS) on PharmaCompass.
A LUPRON DEPOT-PED written confirmation (LUPRON DEPOT-PED WC) is an official document issued by a regulatory agency to a LUPRON DEPOT-PED manufacturer, verifying that the manufacturing facility of a LUPRON DEPOT-PED active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LUPRON DEPOT-PED APIs or LUPRON DEPOT-PED finished pharmaceutical products to another nation, regulatory agencies frequently require a LUPRON DEPOT-PED WC (written confirmation) as part of the regulatory process.
click here to find a list of LUPRON DEPOT-PED 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 DEPOT-PED as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LUPRON DEPOT-PED 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 DEPOT-PED 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 DEPOT-PED and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LUPRON DEPOT-PED NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LUPRON DEPOT-PED suppliers with NDC on PharmaCompass.
LUPRON DEPOT-PED 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 DEPOT-PED 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 DEPOT-PED GMP manufacturer or LUPRON DEPOT-PED GMP API supplier for your needs.
A LUPRON DEPOT-PED CoA (Certificate of Analysis) is a formal document that attests to LUPRON DEPOT-PED's compliance with LUPRON DEPOT-PED specifications and serves as a tool for batch-level quality control.
LUPRON DEPOT-PED CoA mostly includes findings from lab analyses of a specific batch. For each LUPRON DEPOT-PED 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 DEPOT-PED may be tested according to a variety of international standards, such as European Pharmacopoeia (LUPRON DEPOT-PED EP), LUPRON DEPOT-PED JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LUPRON DEPOT-PED USP).
