01 1Cerbios-Pharma SA
02 1GMT Fine Chemicals SA
03 1MERCK & CIE
04 1SEACROSS PHARMACEUTICALS
01 2CALCIUM LEVOFOLINATE
02 1CALCIUM LEVOFOLINATE PENTAHYDRATE
03 1LEVOLEUCOVORIN CALCIUM
01 3Switzerland
02 1United Kingdom
01 4Active
01 2Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-18
DMF Number : 23437
Submission : 2010-01-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2013-09-26
DMF Number : 25198
Submission : 2011-08-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20327
Submission : 2007-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38433
Submission : 2023-05-31
Status : Active
Type : II
A Levoleucovorin Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levoleucovorin Calcium, including repackagers and relabelers. The FDA regulates Levoleucovorin Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levoleucovorin 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 Levoleucovorin Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levoleucovorin Calcium supplier is an individual or a company that provides Levoleucovorin Calcium active pharmaceutical ingredient (API) or Levoleucovorin Calcium finished formulations upon request. The Levoleucovorin Calcium suppliers may include Levoleucovorin Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Levoleucovorin Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levoleucovorin Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Levoleucovorin Calcium active pharmaceutical ingredient (API) in detail. Different forms of Levoleucovorin Calcium DMFs exist exist since differing nations have different regulations, such as Levoleucovorin Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levoleucovorin Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Levoleucovorin Calcium USDMF includes data on Levoleucovorin Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levoleucovorin Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levoleucovorin Calcium suppliers with USDMF on PharmaCompass.
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