01 1Bayer AG
02 1CKD Bio Corporation
03 2CSPC Pharmaceutical Group
04 1HAUDONG MEDICINE CO LTD
05 1Hangzhou Zhongmei Huadong Pharmaceutical
06 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
07 1Livzon New North River Pharmaceutical
08 1Zhejiang Hisun Pharmaceutical
01 6ACARBOSE
02 2ACARBOSE USP
03 1ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE
01 7China
02 1Germany
03 1South Korea
01 8Active
02 1Inactive
01 4Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8539
Submission : 1990-04-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-15
Pay. Date : 2013-02-26
DMF Number : 20759
Submission : 2007-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35603
Submission : 2021-03-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25207
Submission : 2011-07-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37145
Submission : 2022-07-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-22
Pay. Date : 2013-04-11
DMF Number : 18138
Submission : 2005-02-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-07
Pay. Date : 2021-03-17
DMF Number : 35188
Submission : 2020-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23279
Submission : 2009-11-18
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-15
DMF Number : 19069
Submission : 2005-12-14
Status : Active
Type : II
A Acarbose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acarbose, including repackagers and relabelers. The FDA regulates Acarbose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acarbose 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 Acarbose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acarbose supplier is an individual or a company that provides Acarbose active pharmaceutical ingredient (API) or Acarbose finished formulations upon request. The Acarbose suppliers may include Acarbose API manufacturers, exporters, distributors and traders.
click here to find a list of Acarbose suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acarbose DMF (Drug Master File) is a document detailing the whole manufacturing process of Acarbose active pharmaceutical ingredient (API) in detail. Different forms of Acarbose DMFs exist exist since differing nations have different regulations, such as Acarbose USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acarbose DMF submitted to regulatory agencies in the US is known as a USDMF. Acarbose USDMF includes data on Acarbose's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acarbose USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acarbose suppliers with USDMF on PharmaCompass.
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