01 1Fresenius Kabi Oncology Limited
02 1Hetero Drugs
03 1MSN Laboratories
04 1Natco Pharma
05 1Porton Pharma Solutions
06 1ScinoPharm Taiwan Ltd
07 1Sun Pharmaceutical Industries Limited
08 1Blank
01 8ALECTINIB HYDROCHLORIDE
01 1China
02 5India
03 1Taiwan
04 1Blank
01 7Active
02 1Inactive
01 3Complete
02 5Blank
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 : 40093
Submission : 2024-06-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43317
Submission : 2025-12-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-03
Pay. Date : 2025-08-22
DMF Number : 34128
Submission : 2019-12-16
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43810
Submission : 2026-03-31
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
89
PharmaCompass offers a list of Alectinib Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Alectinib Hydrochloride manufacturer or Alectinib Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alectinib Hydrochloride manufacturer or Alectinib Hydrochloride supplier.
A Alectinib HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alectinib HCl, including repackagers and relabelers. The FDA regulates Alectinib HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alectinib HCl 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 HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Alectinib HCl supplier is an individual or a company that provides Alectinib HCl active pharmaceutical ingredient (API) or Alectinib HCl finished formulations upon request. The Alectinib HCl suppliers may include Alectinib HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Alectinib HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Alectinib HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Alectinib HCl active pharmaceutical ingredient (API) in detail. Different forms of Alectinib HCl DMFs exist exist since differing nations have different regulations, such as Alectinib HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alectinib HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Alectinib HCl USDMF includes data on Alectinib HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alectinib HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alectinib HCl suppliers with USDMF on PharmaCompass.
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