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DRUG PRODUCT COMPOSITIONS0
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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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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
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Parenteral
Topical
Solubilizers
Digital Content
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Global Sales Information
US Medicaid Prescriptions
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Patents & EXCLUSIVITIES
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, 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 Lutrate (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutrate (TN), including repackagers and relabelers. The FDA regulates Lutrate (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutrate (TN) 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 Lutrate (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lutrate (TN) supplier is an individual or a company that provides Lutrate (TN) active pharmaceutical ingredient (API) or Lutrate (TN) finished formulations upon request. The Lutrate (TN) suppliers may include Lutrate (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Lutrate (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lutrate (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Lutrate (TN) active pharmaceutical ingredient (API) in detail. Different forms of Lutrate (TN) DMFs exist exist since differing nations have different regulations, such as Lutrate (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lutrate (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Lutrate (TN) USDMF includes data on Lutrate (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lutrate (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lutrate (TN) 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 Lutrate (TN) Drug Master File in Japan (Lutrate (TN) JDMF) empowers Lutrate (TN) 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 Lutrate (TN) JDMF during the approval evaluation for pharmaceutical products. At the time of Lutrate (TN) 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 Lutrate (TN) 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 Lutrate (TN) Drug Master File in Korea (Lutrate (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lutrate (TN). The MFDS reviews the Lutrate (TN) KDMF as part of the drug registration process and uses the information provided in the Lutrate (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lutrate (TN) 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 Lutrate (TN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lutrate (TN) suppliers with KDMF on PharmaCompass.
A Lutrate (TN) CEP of the European Pharmacopoeia monograph is often referred to as a Lutrate (TN) Certificate of Suitability (COS). The purpose of a Lutrate (TN) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lutrate (TN) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lutrate (TN) to their clients by showing that a Lutrate (TN) CEP has been issued for it. The manufacturer submits a Lutrate (TN) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lutrate (TN) CEP holder for the record. Additionally, the data presented in the Lutrate (TN) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lutrate (TN) DMF.
A Lutrate (TN) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lutrate (TN) 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 Lutrate (TN) suppliers with CEP (COS) on PharmaCompass.
A Lutrate (TN) written confirmation (Lutrate (TN) WC) is an official document issued by a regulatory agency to a Lutrate (TN) manufacturer, verifying that the manufacturing facility of a Lutrate (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lutrate (TN) APIs or Lutrate (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Lutrate (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Lutrate (TN) 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 Lutrate (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lutrate (TN) 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 Lutrate (TN) 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 Lutrate (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lutrate (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lutrate (TN) suppliers with NDC on PharmaCompass.
Lutrate (TN) 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 Lutrate (TN) 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 Lutrate (TN) GMP manufacturer or Lutrate (TN) GMP API supplier for your needs.
A Lutrate (TN) CoA (Certificate of Analysis) is a formal document that attests to Lutrate (TN)'s compliance with Lutrate (TN) specifications and serves as a tool for batch-level quality control.
Lutrate (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Lutrate (TN) 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.
Lutrate (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Lutrate (TN) EP), Lutrate (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lutrate (TN) USP).
