Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Alembic Pharmaceuticals Limited
03 1Aurobindo Pharma Limited
04 2MSN Laboratories
05 1Blank
01 2TRAMETINIB
02 1TRAMETINIB ACETIC ACID
03 2TRAMETINIB DIMETHYL SULFOXIDE
04 1TRAMETINIB DIMETHYLSULFOXIDE
01 4India
02 1Poland
03 1Blank
01 6Active
01 2Complete
02 4Blank
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 : 39561
Submission : 2024-06-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40493
Submission : 2024-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-18
Pay. Date : 2022-09-12
DMF Number : 37504
Submission : 2022-09-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-31
Pay. Date : 2022-01-06
DMF Number : 35525
Submission : 2020-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31589
Submission : 2017-03-31
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40250
Submission : 2024-08-23
Status : Active
Type : II
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A Trametinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trametinib, including repackagers and relabelers. The FDA regulates Trametinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trametinib 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 Trametinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trametinib supplier is an individual or a company that provides Trametinib active pharmaceutical ingredient (API) or Trametinib finished formulations upon request. The Trametinib suppliers may include Trametinib API manufacturers, exporters, distributors and traders.
click here to find a list of Trametinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trametinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Trametinib active pharmaceutical ingredient (API) in detail. Different forms of Trametinib DMFs exist exist since differing nations have different regulations, such as Trametinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trametinib DMF submitted to regulatory agencies in the US is known as a USDMF. Trametinib USDMF includes data on Trametinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trametinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trametinib suppliers with USDMF on PharmaCompass.
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