TAPI offers customized CDMO Solutions for API development and manufacturing services.
01 1TAPI Technology & API Services
02 1Emcure Pharmaceuticals
03 1Heraeus Holding
04 1IDT Australia Limited
05 1Indena
06 1Jiangsu Hengrui Medicine
07 1MSN Laboratories
08 1Natco Pharma
09 1SEACROSS PHARMACEUTICALS
10 1Viatris
11 3Blank
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14512
Submission : 1999-10-26
Status :
Type : II
A Thiotepa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thiotepa, including repackagers and relabelers. The FDA regulates Thiotepa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thiotepa 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 Thiotepa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Thiotepa supplier is an individual or a company that provides Thiotepa active pharmaceutical ingredient (API) or Thiotepa finished formulations upon request. The Thiotepa suppliers may include Thiotepa API manufacturers, exporters, distributors and traders.
click here to find a list of Thiotepa suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thiotepa DMF (Drug Master File) is a document detailing the whole manufacturing process of Thiotepa active pharmaceutical ingredient (API) in detail. Different forms of Thiotepa DMFs exist exist since differing nations have different regulations, such as Thiotepa USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thiotepa DMF submitted to regulatory agencies in the US is known as a USDMF. Thiotepa USDMF includes data on Thiotepa's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thiotepa USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thiotepa suppliers with USDMF on PharmaCompass.
We have 10 companies offering Thiotepa
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