Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Metrochem API Private Limited
04 1Porton Pharma Solutions
05 1BrightGene Bio-Medical Technology Co.,Ltd
06 1Cipla
07 1Glenmark Life Sciences
08 1HONOUR LAB LTD
09 1MSN Laboratories
10 1Optimus Pharma
11 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
12 1Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38964
Submission : 2023-10-04
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-08
Pay. Date : 2023-09-28
DMF Number : 38781
Submission : 2023-09-22
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36974
Submission : 2022-05-06
Status :
Type : II
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-25
Pay. Date : 2024-08-28
DMF Number : 39012
Submission : 2023-11-10
Status :
Type : II
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A Isavuconazonium sulfate [USAN] DMF (Drug Master File) is a document detailing the whole manufacturing process of Isavuconazonium sulfate [USAN] active pharmaceutical ingredient (API) in detail. Different forms of Isavuconazonium sulfate [USAN] DMFs exist exist since differing nations have different regulations, such as Isavuconazonium sulfate [USAN] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isavuconazonium sulfate [USAN] DMF submitted to regulatory agencies in the US is known as a USDMF. Isavuconazonium sulfate [USAN] USDMF includes data on Isavuconazonium sulfate [USAN]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isavuconazonium sulfate [USAN] USDMF is kept confidential to protect the manufacturer’s intellectual property.
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