01 1ABX Advanced Biochemical Compounds
02 1ACS DOBFAR SPA
03 1Beijing Friendship Hospital
04 3CIE Alcohol
05 1Divis Laboratories
06 1Euro-Alkohol
07 1GRAIN PROCESSING CORP
08 1Hurum
09 1Koei Chemical
10 1LyondellBasell
11 1Maruti Chemicals
12 1SAFC
13 1Zhejiang Huahai Pharmaceutical
01 1(3S,4R) ALCOHOL COMPOUND
02 1ALCOHOL
03 1ETHANOL
04 1ETHYL ALCOHOL PRODUCTS
05 1Ethanol Ph. Eur.
06 2HIGH GRADE GRAIN NEUTRAL SPIRIT ETHANOL
07 1LITSEA JAPONICA FRUIT ETHANOL EXTRACTS
08 1PREDNACINOLONE ALCOHOL, MICRONIZED & NON MICRONIZED
09 1PYRMETHYL ALCOHOL
10 1RETARDER (09) ETHANOL
11 1TEBOL 99 ALCOHOL (HIGH PURITY TERTIARY BUTYL ALCOHOL) PASEDENA TX
12 1TPE ALCOHOL
13 1USP GRADE ETHYL ALCOHOL
14 1WATER AND/OR ALCOHOL EXTRACTS OF HERBAL COMPOUND 861
01 3China
02 2Germany
03 2India
04 1Italy
05 1Japan
06 1Netherlands
07 5U.S.A
01 7Active
02 8Inactive
01 1Complete
02 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3107
Submission : 1977-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38683
Submission : 2023-09-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31042
Submission : 2016-10-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10498
Submission : 1993-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32513
Submission : 2018-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8191
Submission : 1989-08-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5039
Submission : 1983-07-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34323
Submission : 2019-11-22
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-07
Pay. Date : 2022-04-04
DMF Number : 31348
Submission : 2017-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26756
Submission : 2013-01-30
Status : Active
Type : II
A Ethanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethanol, including repackagers and relabelers. The FDA regulates Ethanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethanol 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 Ethanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ethanol supplier is an individual or a company that provides Ethanol active pharmaceutical ingredient (API) or Ethanol finished formulations upon request. The Ethanol suppliers may include Ethanol API manufacturers, exporters, distributors and traders.
click here to find a list of Ethanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ethanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Ethanol active pharmaceutical ingredient (API) in detail. Different forms of Ethanol DMFs exist exist since differing nations have different regulations, such as Ethanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ethanol DMF submitted to regulatory agencies in the US is known as a USDMF. Ethanol USDMF includes data on Ethanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ethanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ethanol suppliers with USDMF on PharmaCompass.
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