01 1Alembic Pharmaceuticals Limited
02 1Cipla
03 1Emcure Pharmaceuticals
04 1Formosa Laboratories
05 1Maprimed
06 1Unichem Laboratories Limited
01 3LEFLUNOMIDE
02 3LEFLUNOMIDE USP
01 1Argentina
02 4India
03 1Taiwan
01 5Active
02 1Inactive
01 3Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16112
Submission : 2002-08-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-18
Pay. Date : 2015-08-21
DMF Number : 16109
Submission : 2002-08-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16124
Submission : 2002-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2016-08-04
DMF Number : 16038
Submission : 2002-06-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-16
Pay. Date : 2018-09-04
DMF Number : 32988
Submission : 2018-09-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16504
Submission : 2003-03-25
Status : Inactive
Type : II
A Leflunomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leflunomide, including repackagers and relabelers. The FDA regulates Leflunomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leflunomide 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 Leflunomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leflunomide supplier is an individual or a company that provides Leflunomide active pharmaceutical ingredient (API) or Leflunomide finished formulations upon request. The Leflunomide suppliers may include Leflunomide API manufacturers, exporters, distributors and traders.
click here to find a list of Leflunomide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Leflunomide DMF (Drug Master File) is a document detailing the whole manufacturing process of Leflunomide active pharmaceutical ingredient (API) in detail. Different forms of Leflunomide DMFs exist exist since differing nations have different regulations, such as Leflunomide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Leflunomide DMF submitted to regulatory agencies in the US is known as a USDMF. Leflunomide USDMF includes data on Leflunomide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Leflunomide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Leflunomide suppliers with USDMF on PharmaCompass.
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