01 1API Corporation
02 1Biocon
03 1Chongqing DaXin Pharmaceutical
04 1Formosa Laboratories
05 1Hangzhou Zhongmei Huadong Pharmaceutical
06 1JIAOZUO JOINCARE BIOTECHNOLOGICAL CO LTD
07 1Livzon New North River Pharmaceutical
08 1Livzon Pharmaceutical Group
09 1Lunan Pharmaceutical
10 2Olon S.p.A
11 2Sandoz B2B
12 2Zhejiang Hisun Pharmaceutical
01 9MYCOPHENOLIC ACID
02 1MYCOPHENOLIC ACID (NON STERILE BULK FORM)
03 1MYCOPHENOLIC ACID (NON STERILE DRUG SUBSTANCE)
04 1MYCOPHENOLIC ACID NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT
05 1MYCOPHENOLIC ACID NS TECHNICAL GRADE
06 1MYCOPHENOLIC ACID PURE
07 1MYCOPHENOLIC ACID, TECHNICAL GRADE
01 8China
02 1India
03 2Italy
04 1Japan
05 2Switzerland
06 1Taiwan
01 7Active
02 8Inactive
01 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15193
Submission : 2000-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16407
Submission : 2003-01-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20452
Submission : 2007-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21952
Submission : 2008-09-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32389
Submission : 2017-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24977
Submission : 2011-05-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14477
Submission : 1999-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10001
Submission : 1992-12-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15824
Submission : 2002-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26404
Submission : 2012-09-19
Status : Active
Type : II
A Mycophenolic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mycophenolic Acid, including repackagers and relabelers. The FDA regulates Mycophenolic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mycophenolic 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 Mycophenolic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mycophenolic Acid supplier is an individual or a company that provides Mycophenolic Acid active pharmaceutical ingredient (API) or Mycophenolic Acid finished formulations upon request. The Mycophenolic Acid suppliers may include Mycophenolic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Mycophenolic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mycophenolic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Mycophenolic Acid active pharmaceutical ingredient (API) in detail. Different forms of Mycophenolic Acid DMFs exist exist since differing nations have different regulations, such as Mycophenolic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mycophenolic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Mycophenolic Acid USDMF includes data on Mycophenolic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mycophenolic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mycophenolic Acid suppliers with USDMF on PharmaCompass.
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