Synopsis
0
JDMF
0
VMF
0
FDA Orange Book
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Aspen API. More than just an API.
KDMF
ASMF, BR... 
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Aspen API. More than just an API.
Registrant Name : Synex Co., Ltd.
Registration Date : 2010-08-31
Registration Number : 20100831-140-H-28-01
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, Oss, 5347 JN, The Netherlands
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Tibolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tibolone, including repackagers and relabelers. The FDA regulates Tibolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tibolone 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 Tibolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tibolone supplier is an individual or a company that provides Tibolone active pharmaceutical ingredient (API) or Tibolone finished formulations upon request. The Tibolone suppliers may include Tibolone API manufacturers, exporters, distributors and traders.
click here to find a list of Tibolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tibolone DMF (Drug Master File) is a document detailing the whole manufacturing process of Tibolone active pharmaceutical ingredient (API) in detail. Different forms of Tibolone DMFs exist exist since differing nations have different regulations, such as Tibolone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tibolone DMF submitted to regulatory agencies in the US is known as a USDMF. Tibolone USDMF includes data on Tibolone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tibolone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tibolone suppliers with USDMF 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 Tibolone Drug Master File in Korea (Tibolone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tibolone. The MFDS reviews the Tibolone KDMF as part of the drug registration process and uses the information provided in the Tibolone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tibolone 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 Tibolone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tibolone suppliers with KDMF on PharmaCompass.
A Tibolone CEP of the European Pharmacopoeia monograph is often referred to as a Tibolone Certificate of Suitability (COS). The purpose of a Tibolone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tibolone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tibolone to their clients by showing that a Tibolone CEP has been issued for it. The manufacturer submits a Tibolone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tibolone CEP holder for the record. Additionally, the data presented in the Tibolone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tibolone DMF.
A Tibolone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tibolone 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 Tibolone suppliers with CEP (COS) on PharmaCompass.
A Tibolone written confirmation (Tibolone WC) is an official document issued by a regulatory agency to a Tibolone manufacturer, verifying that the manufacturing facility of a Tibolone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tibolone APIs or Tibolone finished pharmaceutical products to another nation, regulatory agencies frequently require a Tibolone WC (written confirmation) as part of the regulatory process.
click here to find a list of Tibolone 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 Tibolone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tibolone 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 Tibolone 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 Tibolone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tibolone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tibolone suppliers with NDC on PharmaCompass.
Tibolone 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 Tibolone 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 Tibolone GMP manufacturer or Tibolone GMP API supplier for your needs.
A Tibolone CoA (Certificate of Analysis) is a formal document that attests to Tibolone's compliance with Tibolone specifications and serves as a tool for batch-level quality control.
Tibolone CoA mostly includes findings from lab analyses of a specific batch. For each Tibolone 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.
Tibolone may be tested according to a variety of international standards, such as European Pharmacopoeia (Tibolone EP), Tibolone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tibolone USP).
LOOKING FOR A SUPPLIER?
