Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
01 1Laboratorium Ofichem B.V
02 2Akzo Nobel Polymer Chem LLC
03 1Suven Pharmaceuticals
01 1DISSOLVINE E-CA-10 (EDETATE CALCIUM DISODIUM USP)
02 1DISSOLVINE NA-2-P (EDETATE DISODIUM USP)
03 1EDETATE CALCIUM DISODIUM
04 1EDETATE CALCIUM DISODIUM DIHYDRATE USP
01 1India
02 1Netherlands
03 2U.S.A
01 2Active
02 2Inactive
01 2Complete
02 2Blank
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-30
Pay. Date : 2022-08-03
DMF Number : 36993
Submission : 2022-07-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10760
Submission : 1994-03-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10759
Submission : 1994-03-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-24
Pay. Date : 2020-10-22
DMF Number : 35275
Submission : 2020-10-01
Status : Active
Type : II
A Edetate Calcium Disodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edetate Calcium Disodium, including repackagers and relabelers. The FDA regulates Edetate Calcium Disodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edetate Calcium Disodium 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 Edetate Calcium Disodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Edetate Calcium Disodium supplier is an individual or a company that provides Edetate Calcium Disodium active pharmaceutical ingredient (API) or Edetate Calcium Disodium finished formulations upon request. The Edetate Calcium Disodium suppliers may include Edetate Calcium Disodium API manufacturers, exporters, distributors and traders.
click here to find a list of Edetate Calcium Disodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Edetate Calcium Disodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Edetate Calcium Disodium active pharmaceutical ingredient (API) in detail. Different forms of Edetate Calcium Disodium DMFs exist exist since differing nations have different regulations, such as Edetate Calcium Disodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Edetate Calcium Disodium DMF submitted to regulatory agencies in the US is known as a USDMF. Edetate Calcium Disodium USDMF includes data on Edetate Calcium Disodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edetate Calcium Disodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Edetate Calcium Disodium suppliers with USDMF on PharmaCompass.
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