01 2BASF
02 2Bayer AG
03 1Flamma SpA
04 1Glenmark Life Sciences
05 1Taro Pharmaceutical Industries
06 1Zhejiang Huahai Pharmaceutical
01 4AZELAIC ACID
02 1AZELAIC ACID (A)
03 1AZELAIC ACID, MICRONIZED
04 1DERMAZ 88 (AZELAIC ACID)
05 1DERMAZ 99 (AZELAIC ACID)
01 1China
02 4Germany
03 1India
04 1Italy
05 1U.S.A
01 8Active
01 4Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-24
Pay. Date : 2014-11-11
DMF Number : 19481
Submission : 2006-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11615
Submission : 1995-08-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9289
Submission : 1991-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28190
Submission : 2014-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38042
Submission : 2023-02-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-15
Pay. Date : 2016-03-10
DMF Number : 29924
Submission : 2016-03-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-05
Pay. Date : 2015-11-30
DMF Number : 29484
Submission : 2015-12-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-17
Pay. Date : 2019-09-30
DMF Number : 33485
Submission : 2019-09-17
Status : Active
Type : II
A Azelaic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azelaic Acid, including repackagers and relabelers. The FDA regulates Azelaic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azelaic 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 Azelaic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azelaic Acid supplier is an individual or a company that provides Azelaic Acid active pharmaceutical ingredient (API) or Azelaic Acid finished formulations upon request. The Azelaic Acid suppliers may include Azelaic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Azelaic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azelaic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Azelaic Acid active pharmaceutical ingredient (API) in detail. Different forms of Azelaic Acid DMFs exist exist since differing nations have different regulations, such as Azelaic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azelaic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Azelaic Acid USDMF includes data on Azelaic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azelaic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azelaic Acid suppliers with USDMF on PharmaCompass.
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