01 1Laboratorio Chimico Internazionale Spa
02 1Olon S.p.A
03 1SHANDONG LUNING PHARMACEUTICAL CO., LTD
04 1SIGMA TAU
01 2ALPHA LIPOIC ACID
02 1DL-6,8-THIOTIC ACID, OXIDIZED FORM CLINICAL STUDIES BY DR. R. JACOBSON
03 1THIOCTIC ACID
01 1China
02 2Italy
03 1U.S.A
01 3Active
02 1Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18998
Submission : 2005-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22211
Submission : 2008-11-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37398
Submission : 2023-08-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4261
Submission : 1981-08-28
Status : Inactive
Type : II
A alpha-Lipoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of alpha-Lipoic Acid, including repackagers and relabelers. The FDA regulates alpha-Lipoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. alpha-Lipoic Acid 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 alpha-Lipoic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A alpha-Lipoic Acid supplier is an individual or a company that provides alpha-Lipoic Acid active pharmaceutical ingredient (API) or alpha-Lipoic Acid finished formulations upon request. The alpha-Lipoic Acid suppliers may include alpha-Lipoic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of alpha-Lipoic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A alpha-Lipoic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of alpha-Lipoic Acid active pharmaceutical ingredient (API) in detail. Different forms of alpha-Lipoic Acid DMFs exist exist since differing nations have different regulations, such as alpha-Lipoic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A alpha-Lipoic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. alpha-Lipoic Acid USDMF includes data on alpha-Lipoic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The alpha-Lipoic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of alpha-Lipoic Acid suppliers with USDMF on PharmaCompass.
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