Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Alkem Laboratories
03 1Apotex Pharmachem
04 2Aurore Life Sciences
05 1Extrovis AG
06 2Hetero Drugs
07 1Jiangsu Hengrui Medicine
08 1Lupin Ltd
09 2MSN Laboratories
10 1Olon S.p.A
11 1Sun Pharmaceutical Industries Limited
12 1Zhejiang Huahai Pharmaceutical
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40469
Submission : 2024-09-19
Status :
Type : II
A Tolvaptan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolvaptan, including repackagers and relabelers. The FDA regulates Tolvaptan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolvaptan 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 Tolvaptan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tolvaptan supplier is an individual or a company that provides Tolvaptan active pharmaceutical ingredient (API) or Tolvaptan finished formulations upon request. The Tolvaptan suppliers may include Tolvaptan API manufacturers, exporters, distributors and traders.
click here to find a list of Tolvaptan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tolvaptan DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolvaptan active pharmaceutical ingredient (API) in detail. Different forms of Tolvaptan DMFs exist exist since differing nations have different regulations, such as Tolvaptan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tolvaptan DMF submitted to regulatory agencies in the US is known as a USDMF. Tolvaptan USDMF includes data on Tolvaptan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolvaptan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tolvaptan suppliers with USDMF on PharmaCompass.
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