Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
01 1Porton Pharma Solutions
02 1Fresenius Kabi Oncology Limited
03 1Hetero Drugs
04 1MSN Laboratories
05 1Natco Pharma
06 1Sun Pharmaceutical Industries Limited
01 6ALECTINIB HYDROCHLORIDE
01 1China
02 5India
01 5Active
02 1Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40093
Submission : 2024-06-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33869
Submission : 2019-06-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39383
Submission : 2024-01-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-19
Pay. Date : 2019-05-28
DMF Number : 33637
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-28
Pay. Date : 2022-03-15
DMF Number : 36908
Submission : 2022-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34128
Submission : 2019-12-16
Status : Active
Type : II
A Alectinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alectinib, including repackagers and relabelers. The FDA regulates Alectinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alectinib 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 Alectinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alectinib supplier is an individual or a company that provides Alectinib active pharmaceutical ingredient (API) or Alectinib finished formulations upon request. The Alectinib suppliers may include Alectinib API manufacturers, exporters, distributors and traders.
click here to find a list of Alectinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alectinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Alectinib active pharmaceutical ingredient (API) in detail. Different forms of Alectinib DMFs exist exist since differing nations have different regulations, such as Alectinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alectinib DMF submitted to regulatory agencies in the US is known as a USDMF. Alectinib USDMF includes data on Alectinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alectinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alectinib suppliers with USDMF on PharmaCompass.
We have 6 companies offering Alectinib
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