01 2Seratec SAS
02 1Siegfried AG
01 3CARBACHOL
01 2France
02 1Switzerland
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35574
Submission : 2021-01-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34783
Submission : 2020-05-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4038
Submission : 1981-01-20
Status : Active
Type : II
A Carbachol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbachol, including repackagers and relabelers. The FDA regulates Carbachol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbachol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Carbachol supplier is an individual or a company that provides Carbachol active pharmaceutical ingredient (API) or Carbachol finished formulations upon request. The Carbachol suppliers may include Carbachol API manufacturers, exporters, distributors and traders.
click here to find a list of Carbachol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbachol DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbachol active pharmaceutical ingredient (API) in detail. Different forms of Carbachol DMFs exist exist since differing nations have different regulations, such as Carbachol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbachol DMF submitted to regulatory agencies in the US is known as a USDMF. Carbachol USDMF includes data on Carbachol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbachol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carbachol suppliers with USDMF on PharmaCompass.
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