Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
01 1Malladi Drugs & Pharmaceuticals Limited
02 1Ami Lifesciences Private Limited
03 1ALP Pharm
04 1Asahi Kasei Finechem
05 1CMIC CMO CO
06 1Daiichi Sankyo
07 1Hunan Dongting Pharmaceutical Co., Ltd.
08 1Kyowa Pharma Chemical Co Ltd
09 2Pfizer Inc
10 2Shilpa Medicare
01 1CYKLOKAPRON TABLETS
02 1THALIDOMIDE USP
03 6TRANEXAMIC ACID
04 1TRANEXAMIC ACID DRUG SUBSTANCE
05 3TRANEXAMIC ACID USP
01 2China
02 4India
03 4Japan
04 2U.S.A
01 8Active
02 4Inactive
01 7Complete
02 5Blank
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37130
Submission : 2022-07-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-11-01
DMF Number : 36336
Submission : 2021-10-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-04
DMF Number : 22277
Submission : 2008-12-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-20
Pay. Date : 2018-12-11
DMF Number : 25331
Submission : 2011-09-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3864
Submission : 1980-07-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-07
DMF Number : 14181
Submission : 1999-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-27
Pay. Date : 2016-05-23
DMF Number : 26128
Submission : 2012-06-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4856
Submission : 1983-02-17
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-04
Pay. Date : 2018-09-04
DMF Number : 33086
Submission : 2018-09-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-12
Pay. Date : 2018-12-19
DMF Number : 33088
Submission : 2018-09-02
Status : Active
Type : II
A Tranexamic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tranexamic Acid, including repackagers and relabelers. The FDA regulates Tranexamic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tranexamic 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 Tranexamic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tranexamic Acid supplier is an individual or a company that provides Tranexamic Acid active pharmaceutical ingredient (API) or Tranexamic Acid finished formulations upon request. The Tranexamic Acid suppliers may include Tranexamic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Tranexamic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tranexamic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Tranexamic Acid active pharmaceutical ingredient (API) in detail. Different forms of Tranexamic Acid DMFs exist exist since differing nations have different regulations, such as Tranexamic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tranexamic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Tranexamic Acid USDMF includes data on Tranexamic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tranexamic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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