Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1ChemWerth Inc
03 1Veranova
04 1ALP Pharm
05 1Hospira, Inc.
06 1MSN Laboratories
07 1Nanjing Pharmaceutical
01 2CLEVIDIPINE
02 3CLEVIDIPINE BUTYRATE
03 1CLEVIDIPINE BUTYRATE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT
04 1CLEVIDIPINE EMULSION
01 2China
02 1India
03 1Spain
04 3U.S.A
01 6Active
02 1Inactive
01 3Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-02
Pay. Date : 2022-03-17
DMF Number : 36436
Submission : 2022-06-14
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-04
Pay. Date : 2020-06-23
DMF Number : 34556
Submission : 2020-06-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16771
Submission : 2003-08-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-25
Pay. Date : 2018-05-25
DMF Number : 29850
Submission : 2016-08-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11365
Submission : 1995-02-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34634
Submission : 2020-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37767
Submission : 2022-12-22
Status : Active
Type : II
A Clevidipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clevidipine, including repackagers and relabelers. The FDA regulates Clevidipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clevidipine 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 Clevidipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clevidipine supplier is an individual or a company that provides Clevidipine active pharmaceutical ingredient (API) or Clevidipine finished formulations upon request. The Clevidipine suppliers may include Clevidipine API manufacturers, exporters, distributors and traders.
click here to find a list of Clevidipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clevidipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Clevidipine active pharmaceutical ingredient (API) in detail. Different forms of Clevidipine DMFs exist exist since differing nations have different regulations, such as Clevidipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clevidipine DMF submitted to regulatory agencies in the US is known as a USDMF. Clevidipine USDMF includes data on Clevidipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clevidipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clevidipine suppliers with USDMF on PharmaCompass.
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