Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1Biocon
03 1BrightGene Bio-Medical Technology Co.,Ltd
04 1Concord Biotech
05 1Curia
01 3PIMECROLIMUS
02 1PIMECROLIMUS (MED 201445/E)
03 1PIMECROLIMUS (NON-STERILE, API)
01 1China
02 2India
03 1Spain
04 1U.S.A
01 5Active
01 5Complete
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-07
Pay. Date : 2015-07-15
DMF Number : 29481
Submission : 2015-07-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-18
Pay. Date : 2014-12-30
DMF Number : 29390
Submission : 2015-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-03
Pay. Date : 2016-01-21
DMF Number : 30090
Submission : 2015-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-23
Pay. Date : 2015-09-02
DMF Number : 29658
Submission : 2015-09-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-15
Pay. Date : 2018-01-24
DMF Number : 32348
Submission : 2017-12-14
Status : Active
Type : II
A Pimecrolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pimecrolimus, including repackagers and relabelers. The FDA regulates Pimecrolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pimecrolimus 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 Pimecrolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pimecrolimus supplier is an individual or a company that provides Pimecrolimus active pharmaceutical ingredient (API) or Pimecrolimus finished formulations upon request. The Pimecrolimus suppliers may include Pimecrolimus API manufacturers, exporters, distributors and traders.
click here to find a list of Pimecrolimus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pimecrolimus DMF (Drug Master File) is a document detailing the whole manufacturing process of Pimecrolimus active pharmaceutical ingredient (API) in detail. Different forms of Pimecrolimus DMFs exist exist since differing nations have different regulations, such as Pimecrolimus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pimecrolimus DMF submitted to regulatory agencies in the US is known as a USDMF. Pimecrolimus USDMF includes data on Pimecrolimus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pimecrolimus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pimecrolimus suppliers with USDMF on PharmaCompass.
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