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KDMF
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VMF
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DRUG PRODUCT COMPOSITIONS0
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL-28 - 0.02MG;1MG
USFDA APPLICATION NUMBER - 17354
DOSAGE - TABLET;ORAL-21 - 0.03MG;1.5MG
USFDA APPLICATION NUMBER - 17355
DOSAGE - TABLET;ORAL-21 - 0.03MG;1.5MG
USFDA APPLICATION NUMBER - 17875
DOSAGE - TABLET;ORAL-21 - 0.02MG;1MG **Federa...DOSAGE - TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17876
DOSAGE - TABLET;ORAL-21 - 0.02MG,0.03MG,0.035...DOSAGE - TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20130
DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal R...DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 203667
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
DOSAGE - CAPSULE;ORAL - 0.02MG;1MG
USFDA APPLICATION NUMBER - 204426
DOSAGE - TABLET, CHEWABLE, TABLET;ORAL - 0.01...DOSAGE - TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A
USFDA APPLICATION NUMBER - 204654
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
USFDA APPLICATION NUMBER - 20870
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
USFDA APPLICATION NUMBER - 20870
DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal ...DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20907
DOSAGE - TABLET;ORAL - 1MG;0.5MG
USFDA APPLICATION NUMBER - 20907
DOSAGE - TABLET;ORAL - 0.0025MG;0.5MG
USFDA APPLICATION NUMBER - 21065
DOSAGE - TABLET;ORAL - 0.005MG;1MG **Federal ...DOSAGE - TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21065
DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal R...DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21871
DOSAGE - TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A
USFDA APPLICATION NUMBER - 22501
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ABOUT THIS PAGE
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PharmaCompass offers a list of Norethisterone 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 Norethisterone Acetate manufacturer or Norethisterone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Norethisterone Acetate manufacturer or Norethisterone Acetate supplier.
PharmaCompass also assists you with knowing the Norethisterone Acetate API Price utilized in the formulation of products. Norethisterone Acetate API Price is not always fixed or binding as the Norethisterone Acetate Price is obtained through a variety of data sources. The Norethisterone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TRI-LEGEST FE-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRI-LEGEST FE-1, including repackagers and relabelers. The FDA regulates TRI-LEGEST FE-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TRI-LEGEST FE-1 supplier is an individual or a company that provides TRI-LEGEST FE-1 active pharmaceutical ingredient (API) or TRI-LEGEST FE-1 finished formulations upon request. The TRI-LEGEST FE-1 suppliers may include TRI-LEGEST FE-1 API manufacturers, exporters, distributors and traders.
click here to find a list of TRI-LEGEST FE-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TRI-LEGEST FE-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of TRI-LEGEST FE-1 active pharmaceutical ingredient (API) in detail. Different forms of TRI-LEGEST FE-1 DMFs exist exist since differing nations have different regulations, such as TRI-LEGEST FE-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TRI-LEGEST FE-1 DMF submitted to regulatory agencies in the US is known as a USDMF. TRI-LEGEST FE-1 USDMF includes data on TRI-LEGEST FE-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TRI-LEGEST FE-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 Drug Master File in Japan (TRI-LEGEST FE-1 JDMF) empowers TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 JDMF during the approval evaluation for pharmaceutical products. At the time of TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 suppliers with JDMF on PharmaCompass.
A TRI-LEGEST FE-1 CEP of the European Pharmacopoeia monograph is often referred to as a TRI-LEGEST FE-1 Certificate of Suitability (COS). The purpose of a TRI-LEGEST FE-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of TRI-LEGEST FE-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of TRI-LEGEST FE-1 to their clients by showing that a TRI-LEGEST FE-1 CEP has been issued for it. The manufacturer submits a TRI-LEGEST FE-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a TRI-LEGEST FE-1 CEP holder for the record. Additionally, the data presented in the TRI-LEGEST FE-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the TRI-LEGEST FE-1 DMF.
A TRI-LEGEST FE-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 suppliers with CEP (COS) on PharmaCompass.
A TRI-LEGEST FE-1 written confirmation (TRI-LEGEST FE-1 WC) is an official document issued by a regulatory agency to a TRI-LEGEST FE-1 manufacturer, verifying that the manufacturing facility of a TRI-LEGEST FE-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TRI-LEGEST FE-1 APIs or TRI-LEGEST FE-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a TRI-LEGEST FE-1 WC (written confirmation) as part of the regulatory process.
click here to find a list of TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TRI-LEGEST FE-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TRI-LEGEST FE-1 suppliers with NDC on PharmaCompass.
TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 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 TRI-LEGEST FE-1 GMP manufacturer or TRI-LEGEST FE-1 GMP API supplier for your needs.
A TRI-LEGEST FE-1 CoA (Certificate of Analysis) is a formal document that attests to TRI-LEGEST FE-1's compliance with TRI-LEGEST FE-1 specifications and serves as a tool for batch-level quality control.
TRI-LEGEST FE-1 CoA mostly includes findings from lab analyses of a specific batch. For each TRI-LEGEST FE-1 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.
TRI-LEGEST FE-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (TRI-LEGEST FE-1 EP), TRI-LEGEST FE-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TRI-LEGEST FE-1 USP).
