01 1Fresenius Kabi Oncology Limited
02 1Hetero Drugs
03 1MSN Laboratories
04 1Natco Pharma
05 1Porton Pharma Solutions
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 : 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 : 34128
Submission : 2019-12-16
Status : Active
Type : II
23
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A CAS 1256580-46-7 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS 1256580-46-7, including repackagers and relabelers. The FDA regulates CAS 1256580-46-7 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS 1256580-46-7 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A CAS 1256580-46-7 supplier is an individual or a company that provides CAS 1256580-46-7 active pharmaceutical ingredient (API) or CAS 1256580-46-7 finished formulations upon request. The CAS 1256580-46-7 suppliers may include CAS 1256580-46-7 API manufacturers, exporters, distributors and traders.
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A CAS 1256580-46-7 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS 1256580-46-7 active pharmaceutical ingredient (API) in detail. Different forms of CAS 1256580-46-7 DMFs exist exist since differing nations have different regulations, such as CAS 1256580-46-7 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS 1256580-46-7 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS 1256580-46-7 USDMF includes data on CAS 1256580-46-7's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS 1256580-46-7 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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