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 2Metrochem 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
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 : 39823
Submission : 2024-04-30
Status :
Type : II
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A Isavuconazonium Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isavuconazonium Sulfate, including repackagers and relabelers. The FDA regulates Isavuconazonium Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isavuconazonium Sulfate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Isavuconazonium Sulfate supplier is an individual or a company that provides Isavuconazonium Sulfate active pharmaceutical ingredient (API) or Isavuconazonium Sulfate finished formulations upon request. The Isavuconazonium Sulfate suppliers may include Isavuconazonium Sulfate API manufacturers, exporters, distributors and traders.
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A Isavuconazonium Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Isavuconazonium Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Isavuconazonium Sulfate DMFs exist exist since differing nations have different regulations, such as Isavuconazonium Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isavuconazonium Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Isavuconazonium Sulfate USDMF includes data on Isavuconazonium Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isavuconazonium Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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