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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