01 1MSN Laboratories
02 1Olon S.p.A
03 1Raks Pharma
04 1Resonance Laboratories Pvt. Ltd
05 1Sifavitor srl
01 1CLIDINIUM BROMIDE
02 3CLIDINIUM BROMIDE USP
03 1CLIDINIUM BROMIDE, USP
01 3India
02 2Italy
01 5Active
01 3Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-09
Pay. Date : 2019-06-21
DMF Number : 32674
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-08
Pay. Date : 2017-04-13
DMF Number : 2809
Submission : 1976-12-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-18
Pay. Date : 2020-09-18
DMF Number : 35186
Submission : 2020-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24725
Submission : 2011-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3659
Submission : 1979-11-15
Status : Active
Type : II
A Clidinium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clidinium, including repackagers and relabelers. The FDA regulates Clidinium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clidinium 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 Clidinium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clidinium supplier is an individual or a company that provides Clidinium active pharmaceutical ingredient (API) or Clidinium finished formulations upon request. The Clidinium suppliers may include Clidinium API manufacturers, exporters, distributors and traders.
click here to find a list of Clidinium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clidinium DMF (Drug Master File) is a document detailing the whole manufacturing process of Clidinium active pharmaceutical ingredient (API) in detail. Different forms of Clidinium DMFs exist exist since differing nations have different regulations, such as Clidinium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clidinium DMF submitted to regulatory agencies in the US is known as a USDMF. Clidinium USDMF includes data on Clidinium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clidinium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clidinium suppliers with USDMF on PharmaCompass.
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