01 1Anthem Biosciences
02 1Cerbios-Pharma SA
03 1Chemspec-API
04 1Lupin Ltd
01 1(6S)-5-METHYLTETRAHYDROFOLIC ACID CALCIUM SALT
02 2CALCIUM L-5-METHYLTETRAHYDROFOLATE USP
03 1CALCIUM LEVOMEFOLATE
01 2India
02 1Switzerland
03 1U.S.A
01 4Active
01 3Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-17
Pay. Date : 2021-12-14
DMF Number : 36528
Submission : 2021-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-08-31
DMF Number : 26016
Submission : 2012-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25789
Submission : 2013-03-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-04-03
DMF Number : 26531
Submission : 2013-03-12
Status : Active
Type : II
A Levomefolate Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levomefolate Calcium, including repackagers and relabelers. The FDA regulates Levomefolate Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levomefolate Calcium 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 Levomefolate Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levomefolate Calcium supplier is an individual or a company that provides Levomefolate Calcium active pharmaceutical ingredient (API) or Levomefolate Calcium finished formulations upon request. The Levomefolate Calcium suppliers may include Levomefolate Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Levomefolate Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levomefolate Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Levomefolate Calcium active pharmaceutical ingredient (API) in detail. Different forms of Levomefolate Calcium DMFs exist exist since differing nations have different regulations, such as Levomefolate Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levomefolate Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Levomefolate Calcium USDMF includes data on Levomefolate Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levomefolate Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levomefolate Calcium suppliers with USDMF on PharmaCompass.
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