01 1MSN Laboratories
02 1Shilpa Medicare
01 1PEMETREXED DIPOTASSIUM (NONA HYDRATE) (PMN)
02 1PEMETREXED DIPOTASSIUM HEPTAHYDRATE
01 2India
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31571
Submission : 2017-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-15
Pay. Date : 2015-09-23
DMF Number : 29652
Submission : 2015-09-14
Status : Active
Type : II
A Pemetrexed Dipotassium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pemetrexed Dipotassium, including repackagers and relabelers. The FDA regulates Pemetrexed Dipotassium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pemetrexed Dipotassium 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 Pemetrexed Dipotassium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pemetrexed Dipotassium supplier is an individual or a company that provides Pemetrexed Dipotassium active pharmaceutical ingredient (API) or Pemetrexed Dipotassium finished formulations upon request. The Pemetrexed Dipotassium suppliers may include Pemetrexed Dipotassium API manufacturers, exporters, distributors and traders.
click here to find a list of Pemetrexed Dipotassium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pemetrexed Dipotassium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pemetrexed Dipotassium active pharmaceutical ingredient (API) in detail. Different forms of Pemetrexed Dipotassium DMFs exist exist since differing nations have different regulations, such as Pemetrexed Dipotassium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pemetrexed Dipotassium DMF submitted to regulatory agencies in the US is known as a USDMF. Pemetrexed Dipotassium USDMF includes data on Pemetrexed Dipotassium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pemetrexed Dipotassium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pemetrexed Dipotassium suppliers with USDMF on PharmaCompass.
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