Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Porton Pharma Solutions
03 1MSN Laboratories
04 1OKAMI CHEMICAL INDUSTRY CO LTD
05 1Santen Pharmaceutical
06 1Sun Pharmaceutical Industries Limited
07 1Suzhou Ryway Biotech
01 1THIOLA
02 5TIOPRONIN
03 1TIOPRONIN NON-STERILE BULK DRUG
01 2China
02 3India
03 2Japan
01 5Active
02 2Inactive
01 3Complete
02 4Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-07
Pay. Date : 2021-08-18
DMF Number : 35512
Submission : 2020-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29447
Submission : 2015-06-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-29
Pay. Date : 2018-03-14
DMF Number : 32011
Submission : 2017-10-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6740
Submission : 1986-12-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3446
Submission : 1979-02-06
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-15
Pay. Date : 2024-01-25
DMF Number : 39427
Submission : 2024-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39136
Submission : 2023-11-13
Status : Active
Type : II
A Tiopronin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tiopronin, including repackagers and relabelers. The FDA regulates Tiopronin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tiopronin 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 Tiopronin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tiopronin supplier is an individual or a company that provides Tiopronin active pharmaceutical ingredient (API) or Tiopronin finished formulations upon request. The Tiopronin suppliers may include Tiopronin API manufacturers, exporters, distributors and traders.
click here to find a list of Tiopronin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tiopronin DMF (Drug Master File) is a document detailing the whole manufacturing process of Tiopronin active pharmaceutical ingredient (API) in detail. Different forms of Tiopronin DMFs exist exist since differing nations have different regulations, such as Tiopronin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tiopronin DMF submitted to regulatory agencies in the US is known as a USDMF. Tiopronin USDMF includes data on Tiopronin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tiopronin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tiopronin suppliers with USDMF on PharmaCompass.
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