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1. 74381-53-6
2. Leuprorelin Acetate;h-pyr-his-trp-ser-tyr-d-leu-leu-arg-pro-nhet.ch3co2h
3. Lupron (tn)
4. Mfcd00072080
5. Fensolvi (tn)
6. Eligard (tn)
7. Lutrate (tn)
8. Leuprolide Acetate (usp)
9. Leuprorelin Acetate (jp17)
10. Schembl1651429
11. 5-oxopro-his-trp-ser-tyr-d-leu-leu-arg-pronhc2h5 Dihydrate
12. Amy12301
13. Nsc746847
14. Nsc-746847
15. Sy225936
16. Ft-0627807
17. D00989
18. Leuprorelin Acetate; Lupron; Leuprolide Acetate
| Molecular Weight | 1269.4 g/mol |
|---|---|
| Molecular Formula | C61H88N16O14 |
| Hydrogen Bond Donor Count | 16 |
| Hydrogen Bond Acceptor Count | 16 |
| Rotatable Bond Count | 32 |
| Exact Mass | 1268.66659154 g/mol |
| Monoisotopic Mass | 1268.66659154 g/mol |
| Topological Polar Surface Area | 469 Ų |
| Heavy Atom Count | 91 |
| Formal Charge | 0 |
| Complexity | 2420 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 9 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Leuprolide acetate |
| Drug Label | Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-s... |
| Active Ingredient | Leuprolide acetate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 1mg/0.2ml |
| Market Status | Prescription |
| Company | Teva Pharms Usa; Sandoz; Sun Pharma Global |
| 2 of 2 | |
|---|---|
| Drug Name | Leuprolide acetate |
| Drug Label | Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-s... |
| Active Ingredient | Leuprolide acetate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 1mg/0.2ml |
| Market Status | Prescription |
| Company | Teva Pharms Usa; Sandoz; Sun Pharma Global |
API SUPPLIERS
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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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
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ABOUT THIS PAGE
A Leuprolide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leuprolide, including repackagers and relabelers. The FDA regulates Leuprolide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leuprolide 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 Leuprolide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leuprolide supplier is an individual or a company that provides Leuprolide active pharmaceutical ingredient (API) or Leuprolide finished formulations upon request. The Leuprolide suppliers may include Leuprolide API manufacturers, exporters, distributors and traders.
click here to find a list of Leuprolide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Leuprolide DMF (Drug Master File) is a document detailing the whole manufacturing process of Leuprolide active pharmaceutical ingredient (API) in detail. Different forms of Leuprolide DMFs exist exist since differing nations have different regulations, such as Leuprolide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Leuprolide DMF submitted to regulatory agencies in the US is known as a USDMF. Leuprolide USDMF includes data on Leuprolide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Leuprolide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Leuprolide 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 Leuprolide Drug Master File in Japan (Leuprolide JDMF) empowers Leuprolide 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 Leuprolide JDMF during the approval evaluation for pharmaceutical products. At the time of Leuprolide 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 Leuprolide 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 Leuprolide Drug Master File in Korea (Leuprolide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Leuprolide. The MFDS reviews the Leuprolide KDMF as part of the drug registration process and uses the information provided in the Leuprolide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Leuprolide 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 Leuprolide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Leuprolide suppliers with KDMF on PharmaCompass.
A Leuprolide CEP of the European Pharmacopoeia monograph is often referred to as a Leuprolide Certificate of Suitability (COS). The purpose of a Leuprolide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Leuprolide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Leuprolide to their clients by showing that a Leuprolide CEP has been issued for it. The manufacturer submits a Leuprolide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Leuprolide CEP holder for the record. Additionally, the data presented in the Leuprolide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Leuprolide DMF.
A Leuprolide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Leuprolide 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 Leuprolide suppliers with CEP (COS) on PharmaCompass.
A Leuprolide written confirmation (Leuprolide WC) is an official document issued by a regulatory agency to a Leuprolide manufacturer, verifying that the manufacturing facility of a Leuprolide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Leuprolide APIs or Leuprolide finished pharmaceutical products to another nation, regulatory agencies frequently require a Leuprolide WC (written confirmation) as part of the regulatory process.
click here to find a list of Leuprolide 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 Leuprolide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Leuprolide 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 Leuprolide 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 Leuprolide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Leuprolide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Leuprolide suppliers with NDC on PharmaCompass.
Leuprolide 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 Leuprolide 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 Leuprolide GMP manufacturer or Leuprolide GMP API supplier for your needs.
A Leuprolide CoA (Certificate of Analysis) is a formal document that attests to Leuprolide's compliance with Leuprolide specifications and serves as a tool for batch-level quality control.
Leuprolide CoA mostly includes findings from lab analyses of a specific batch. For each Leuprolide 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.
Leuprolide may be tested according to a variety of international standards, such as European Pharmacopoeia (Leuprolide EP), Leuprolide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Leuprolide USP).
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