01 1Albert David
02 1Alfasigma
03 1Kothari Phytochemicals & Industries
04 1Labochem Ltd
05 1Medimpex
06 1Napp Technologies
07 2Pfizer Inc
08 2Blank
01 1MANUFACTURING & CONTROLS PROCEDURES USED IN PRODUCTION OF TOLBUTAMIDE
02 1ORINASE
03 1TOLBUTAMIDE
04 1TOLBUTAMIDE BULK
05 2TOLBUTAMIDE USP
06 1TOLBUTAMIDE USP (BULK)
07 1TOLBUTAMIDE USP XIX
08 1TOLBUTAMIDE USP, BULK FORM
09 1TOLBUTAMIDE, USP AND TOLBUTAMIDE, USP MILLED
01 1Greece
02 2India
03 1Italy
04 3U.S.A
05 1United Kingdom
06 2Blank
01 1Active
02 9Inactive
01 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5982
Submission : 1985-09-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 466
Submission : 1962-02-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25168
Submission : 2011-07-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4360
Submission : 1981-10-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3270
Submission : 1978-08-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3540
Submission : 1979-04-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4739
Submission : 1982-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 197
Submission : 1956-05-02
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5320
Submission : 1984-04-06
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5601
Submission : 1984-10-03
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Tolbutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolbutamide, including repackagers and relabelers. The FDA regulates Tolbutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolbutamide 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 Tolbutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tolbutamide supplier is an individual or a company that provides Tolbutamide active pharmaceutical ingredient (API) or Tolbutamide finished formulations upon request. The Tolbutamide suppliers may include Tolbutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Tolbutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tolbutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolbutamide active pharmaceutical ingredient (API) in detail. Different forms of Tolbutamide DMFs exist exist since differing nations have different regulations, such as Tolbutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tolbutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Tolbutamide USDMF includes data on Tolbutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolbutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tolbutamide suppliers with USDMF on PharmaCompass.
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