01 1Corden Pharma Bergamo S.p.A
02 1Seratec SAS
03 1Siegfried AG
04 1Wockhardt
05 3Blank
01 5BETHANECHOL CHLORIDE
02 2BETHANECHOL CHLORIDE USP
01 1France
02 1India
03 1Italy
04 1Switzerland
05 3Blank
01 3Active
02 4Inactive
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15213
Submission : 2000-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15866
Submission : 2002-02-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-28
Pay. Date : 2018-12-20
DMF Number : 15737
Submission : 2001-11-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16119
Submission : 2002-08-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4348
Submission : 1981-12-08
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 : 2501
Submission : 1975-07-25
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 : 4766
Submission : 1982-12-10
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Bethanechol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bethanechol, including repackagers and relabelers. The FDA regulates Bethanechol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bethanechol 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 Bethanechol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bethanechol supplier is an individual or a company that provides Bethanechol active pharmaceutical ingredient (API) or Bethanechol finished formulations upon request. The Bethanechol suppliers may include Bethanechol API manufacturers, exporters, distributors and traders.
click here to find a list of Bethanechol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bethanechol DMF (Drug Master File) is a document detailing the whole manufacturing process of Bethanechol active pharmaceutical ingredient (API) in detail. Different forms of Bethanechol DMFs exist exist since differing nations have different regulations, such as Bethanechol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bethanechol DMF submitted to regulatory agencies in the US is known as a USDMF. Bethanechol USDMF includes data on Bethanechol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bethanechol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bethanechol suppliers with USDMF on PharmaCompass.
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