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
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alectinib Hydrochloride, including repackagers and relabelers. The FDA regulates Alectinib Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alectinib Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alectinib Hydrochloride supplier is an individual or a company that provides Alectinib Hydrochloride active pharmaceutical ingredient (API) or Alectinib Hydrochloride finished formulations upon request. The Alectinib Hydrochloride suppliers may include Alectinib Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Alectinib Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alectinib Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Alectinib Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Alectinib Hydrochloride DMFs exist exist since differing nations have different regulations, such as Alectinib Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alectinib Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Alectinib Hydrochloride USDMF includes data on Alectinib Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alectinib Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alectinib Hydrochloride suppliers with USDMF on PharmaCompass.
We have 6 companies offering Alectinib Hydrochloride
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