01 1APEX HEALTHCARE LIMITED
02 1Cambrex Corporation
03 1Dishman Carbogen Amcis
04 1Erregierre SpA
05 1Kreative Organics
01 2BISACODYL
02 2BISACODYL USP
03 1BISACODYL USP-EP
01 3India
02 1Italy
03 1U.S.A
01 5Active
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36474
Submission : 2022-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2248
Submission : 1974-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20476
Submission : 2007-04-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14947
Submission : 2000-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16058
Submission : 2002-06-28
Status : Active
Type : II
A Bisacodyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bisacodyl, including repackagers and relabelers. The FDA regulates Bisacodyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bisacodyl 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 Bisacodyl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bisacodyl supplier is an individual or a company that provides Bisacodyl active pharmaceutical ingredient (API) or Bisacodyl finished formulations upon request. The Bisacodyl suppliers may include Bisacodyl API manufacturers, exporters, distributors and traders.
click here to find a list of Bisacodyl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bisacodyl DMF (Drug Master File) is a document detailing the whole manufacturing process of Bisacodyl active pharmaceutical ingredient (API) in detail. Different forms of Bisacodyl DMFs exist exist since differing nations have different regulations, such as Bisacodyl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bisacodyl DMF submitted to regulatory agencies in the US is known as a USDMF. Bisacodyl USDMF includes data on Bisacodyl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bisacodyl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bisacodyl suppliers with USDMF on PharmaCompass.
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