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API SUPPLIERS
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USDMF
Aspen API. More than just an API™
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3877
Submission : 1980-06-25
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-26
Pay. Date : 2018-04-17
DMF Number : 26166
Submission : 2012-06-19
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3781
Submission : 1980-04-15
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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ABOUT THIS PAGE
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PharmaCompass offers a list of Testosterone Enanthate 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 Testosterone Enanthate manufacturer or Testosterone Enanthate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Testosterone Enanthate manufacturer or Testosterone Enanthate supplier.
PharmaCompass also assists you with knowing the Testosterone Enanthate API Price utilized in the formulation of products. Testosterone Enanthate API Price is not always fixed or binding as the Testosterone Enanthate Price is obtained through a variety of data sources. The Testosterone Enanthate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Testosterone Enanthate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Testosterone Enanthate, including repackagers and relabelers. The FDA regulates Testosterone Enanthate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Testosterone Enanthate 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 Testosterone Enanthate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Testosterone Enanthate supplier is an individual or a company that provides Testosterone Enanthate active pharmaceutical ingredient (API) or Testosterone Enanthate finished formulations upon request. The Testosterone Enanthate suppliers may include Testosterone Enanthate API manufacturers, exporters, distributors and traders.
click here to find a list of Testosterone Enanthate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Testosterone Enanthate DMF (Drug Master File) is a document detailing the whole manufacturing process of Testosterone Enanthate active pharmaceutical ingredient (API) in detail. Different forms of Testosterone Enanthate DMFs exist exist since differing nations have different regulations, such as Testosterone Enanthate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Testosterone Enanthate DMF submitted to regulatory agencies in the US is known as a USDMF. Testosterone Enanthate USDMF includes data on Testosterone Enanthate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Testosterone Enanthate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Testosterone Enanthate 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 Testosterone Enanthate Drug Master File in Japan (Testosterone Enanthate JDMF) empowers Testosterone Enanthate 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 Testosterone Enanthate JDMF during the approval evaluation for pharmaceutical products. At the time of Testosterone Enanthate 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 Testosterone Enanthate suppliers with JDMF on PharmaCompass.
A Testosterone Enanthate CEP of the European Pharmacopoeia monograph is often referred to as a Testosterone Enanthate Certificate of Suitability (COS). The purpose of a Testosterone Enanthate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Testosterone Enanthate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Testosterone Enanthate to their clients by showing that a Testosterone Enanthate CEP has been issued for it. The manufacturer submits a Testosterone Enanthate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Testosterone Enanthate CEP holder for the record. Additionally, the data presented in the Testosterone Enanthate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Testosterone Enanthate DMF.
A Testosterone Enanthate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Testosterone Enanthate 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 Testosterone Enanthate suppliers with CEP (COS) on PharmaCompass.
A Testosterone Enanthate written confirmation (Testosterone Enanthate WC) is an official document issued by a regulatory agency to a Testosterone Enanthate manufacturer, verifying that the manufacturing facility of a Testosterone Enanthate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Testosterone Enanthate APIs or Testosterone Enanthate finished pharmaceutical products to another nation, regulatory agencies frequently require a Testosterone Enanthate WC (written confirmation) as part of the regulatory process.
click here to find a list of Testosterone Enanthate 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 Testosterone Enanthate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Testosterone Enanthate 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 Testosterone Enanthate 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 Testosterone Enanthate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Testosterone Enanthate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Testosterone Enanthate suppliers with NDC on PharmaCompass.
Testosterone Enanthate 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 Testosterone Enanthate 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 Testosterone Enanthate GMP manufacturer or Testosterone Enanthate GMP API supplier for your needs.
A Testosterone Enanthate CoA (Certificate of Analysis) is a formal document that attests to Testosterone Enanthate's compliance with Testosterone Enanthate specifications and serves as a tool for batch-level quality control.
Testosterone Enanthate CoA mostly includes findings from lab analyses of a specific batch. For each Testosterone Enanthate 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.
Testosterone Enanthate may be tested according to a variety of international standards, such as European Pharmacopoeia (Testosterone Enanthate EP), Testosterone Enanthate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Testosterone Enanthate USP).
