01 2Enteris Biopharma Inc
02 1Flamma SpA
01 23-O-LAUROYL-L-CARNITINE HYDROCHLORIDE (LLC)
02 1LAUROYL-L-CARNITINE HYDROCHLORIDE
01 1Italy
02 2U.S.A
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32916
Submission : 2018-08-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35467
Submission : 2021-08-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39270
Submission : 2023-12-20
Status : Active
Type : II
26
PharmaCompass offers a list of PDBBUDRTWRVCFN-UNTBIKODSA-N API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right PDBBUDRTWRVCFN-UNTBIKODSA-N manufacturer or PDBBUDRTWRVCFN-UNTBIKODSA-N supplier for your needs.
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A PDBBUDRTWRVCFN-UNTBIKODSA-N manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PDBBUDRTWRVCFN-UNTBIKODSA-N, including repackagers and relabelers. The FDA regulates PDBBUDRTWRVCFN-UNTBIKODSA-N manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PDBBUDRTWRVCFN-UNTBIKODSA-N API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A PDBBUDRTWRVCFN-UNTBIKODSA-N supplier is an individual or a company that provides PDBBUDRTWRVCFN-UNTBIKODSA-N active pharmaceutical ingredient (API) or PDBBUDRTWRVCFN-UNTBIKODSA-N finished formulations upon request. The PDBBUDRTWRVCFN-UNTBIKODSA-N suppliers may include PDBBUDRTWRVCFN-UNTBIKODSA-N API manufacturers, exporters, distributors and traders.
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A PDBBUDRTWRVCFN-UNTBIKODSA-N DMF (Drug Master File) is a document detailing the whole manufacturing process of PDBBUDRTWRVCFN-UNTBIKODSA-N active pharmaceutical ingredient (API) in detail. Different forms of PDBBUDRTWRVCFN-UNTBIKODSA-N DMFs exist exist since differing nations have different regulations, such as PDBBUDRTWRVCFN-UNTBIKODSA-N USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PDBBUDRTWRVCFN-UNTBIKODSA-N DMF submitted to regulatory agencies in the US is known as a USDMF. PDBBUDRTWRVCFN-UNTBIKODSA-N USDMF includes data on PDBBUDRTWRVCFN-UNTBIKODSA-N's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PDBBUDRTWRVCFN-UNTBIKODSA-N USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 2 companies offering PDBBUDRTWRVCFN-UNTBIKODSA-N
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