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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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Regulatory Info :
Registration Country : Italy
Brand Name : Kessar
Dosage Form : Tamoxifen 10Mg 30 Joined' Oral Use
Dosage Strength : 30 CPR 10 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Kessar
Dosage Form : Tamoxifen 20Mg 30 Joined' Oral Use
Dosage Strength : 30 CPR 20 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17970
DOSAGE - TABLET;ORAL - EQ 20MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17970
DOSAGE - SOLUTION;ORAL - EQ 20MG BASE/10ML
USFDA APPLICATION NUMBER - 21807
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ABOUT THIS PAGE
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PharmaCompass offers a list of Tamoxifen Citrate 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 Tamoxifen Citrate manufacturer or Tamoxifen Citrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tamoxifen Citrate manufacturer or Tamoxifen Citrate supplier.
PharmaCompass also assists you with knowing the Tamoxifen Citrate API Price utilized in the formulation of products. Tamoxifen Citrate API Price is not always fixed or binding as the Tamoxifen Citrate Price is obtained through a variety of data sources. The Tamoxifen Citrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tamoxifen Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tamoxifen Citrate, including repackagers and relabelers. The FDA regulates Tamoxifen Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tamoxifen Citrate 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 Tamoxifen Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tamoxifen Citrate supplier is an individual or a company that provides Tamoxifen Citrate active pharmaceutical ingredient (API) or Tamoxifen Citrate finished formulations upon request. The Tamoxifen Citrate suppliers may include Tamoxifen Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Tamoxifen Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tamoxifen Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Tamoxifen Citrate active pharmaceutical ingredient (API) in detail. Different forms of Tamoxifen Citrate DMFs exist exist since differing nations have different regulations, such as Tamoxifen Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tamoxifen Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Tamoxifen Citrate USDMF includes data on Tamoxifen Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tamoxifen Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tamoxifen Citrate 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 Tamoxifen Citrate Drug Master File in Japan (Tamoxifen Citrate JDMF) empowers Tamoxifen Citrate 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 Tamoxifen Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Tamoxifen Citrate 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 Tamoxifen Citrate 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 Tamoxifen Citrate Drug Master File in Korea (Tamoxifen Citrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tamoxifen Citrate. The MFDS reviews the Tamoxifen Citrate KDMF as part of the drug registration process and uses the information provided in the Tamoxifen Citrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tamoxifen Citrate 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 Tamoxifen Citrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tamoxifen Citrate suppliers with KDMF on PharmaCompass.
A Tamoxifen Citrate CEP of the European Pharmacopoeia monograph is often referred to as a Tamoxifen Citrate Certificate of Suitability (COS). The purpose of a Tamoxifen Citrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tamoxifen Citrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tamoxifen Citrate to their clients by showing that a Tamoxifen Citrate CEP has been issued for it. The manufacturer submits a Tamoxifen Citrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tamoxifen Citrate CEP holder for the record. Additionally, the data presented in the Tamoxifen Citrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tamoxifen Citrate DMF.
A Tamoxifen Citrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tamoxifen Citrate 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 Tamoxifen Citrate suppliers with CEP (COS) 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 Tamoxifen Citrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tamoxifen Citrate 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 Tamoxifen Citrate 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 Tamoxifen Citrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tamoxifen Citrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tamoxifen Citrate suppliers with NDC on PharmaCompass.
Tamoxifen Citrate 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 Tamoxifen Citrate 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 Tamoxifen Citrate GMP manufacturer or Tamoxifen Citrate GMP API supplier for your needs.
A Tamoxifen Citrate CoA (Certificate of Analysis) is a formal document that attests to Tamoxifen Citrate's compliance with Tamoxifen Citrate specifications and serves as a tool for batch-level quality control.
Tamoxifen Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Tamoxifen Citrate 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.
Tamoxifen Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tamoxifen Citrate EP), Tamoxifen Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tamoxifen Citrate USP).
