Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ChemWerth Inc
03 1TAPI Technology & API Services
04 1Steroid SpA
01 3DIFLUPREDNATE
02 1DIFLUPREDNATE (MICRONIZED)
01 1Germany
02 1Israel
03 1Italy
04 1U.S.A
01 4Active
01 3Complete
02 1Blank
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-04-14
DMF Number : 25228
Submission : 2011-08-23
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-13
Pay. Date : 2013-08-05
DMF Number : 26378
Submission : 2013-07-22
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-26
Pay. Date : 2015-10-21
DMF Number : 19870
Submission : 2006-10-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32778
Submission : 2018-05-10
Status : Active
Type : II
A Difluprednate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difluprednate, including repackagers and relabelers. The FDA regulates Difluprednate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difluprednate 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 Difluprednate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Difluprednate supplier is an individual or a company that provides Difluprednate active pharmaceutical ingredient (API) or Difluprednate finished formulations upon request. The Difluprednate suppliers may include Difluprednate API manufacturers, exporters, distributors and traders.
click here to find a list of Difluprednate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Difluprednate DMF (Drug Master File) is a document detailing the whole manufacturing process of Difluprednate active pharmaceutical ingredient (API) in detail. Different forms of Difluprednate DMFs exist exist since differing nations have different regulations, such as Difluprednate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Difluprednate DMF submitted to regulatory agencies in the US is known as a USDMF. Difluprednate USDMF includes data on Difluprednate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Difluprednate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Difluprednate suppliers with USDMF on PharmaCompass.
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