01 1Merck & Co
02 1Qinhuangdao Zizhu Pharmaceutical
01 2TIBOLONE
01 1China
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13895
Submission : 1998-12-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29217
Submission : 2015-03-26
Status : Active
Type : II
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PharmaCompass offers a list of Tibolone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Tibolone manufacturer or Tibolone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tibolone manufacturer or Tibolone supplier.
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, and COA 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, and COA 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.
We have 2 companies offering Tibolone
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