01 1Aurobindo Pharma Limited
02 1Lupin Ltd
03 1MSN Laboratories
04 1Zydus Lifesciences
01 1LORCASERIN HYDROCHLORIDE
02 1LORCASERIN HYDROCHLORIDE HEMIHYDRATE
03 1LORCASERIN HYDROCHLORIDE HEMIHYDRATE [ROUTE CODE "LC"]
04 1LORCASERIN HYDROCHLORIDE PREMIX
01 4India
01 3Active
02 1Inactive
01 3Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-04
Pay. Date : 2015-12-29
DMF Number : 30118
Submission : 2015-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29910
Submission : 2015-12-24
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-28
Pay. Date : 2017-05-22
DMF Number : 29205
Submission : 2015-04-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2016-02-17
DMF Number : 30277
Submission : 2016-03-26
Status : Active
Type : II
A Lorcaserin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lorcaserin, including repackagers and relabelers. The FDA regulates Lorcaserin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lorcaserin 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 Lorcaserin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lorcaserin supplier is an individual or a company that provides Lorcaserin active pharmaceutical ingredient (API) or Lorcaserin finished formulations upon request. The Lorcaserin suppliers may include Lorcaserin API manufacturers, exporters, distributors and traders.
click here to find a list of Lorcaserin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lorcaserin DMF (Drug Master File) is a document detailing the whole manufacturing process of Lorcaserin active pharmaceutical ingredient (API) in detail. Different forms of Lorcaserin DMFs exist exist since differing nations have different regulations, such as Lorcaserin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lorcaserin DMF submitted to regulatory agencies in the US is known as a USDMF. Lorcaserin USDMF includes data on Lorcaserin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lorcaserin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lorcaserin suppliers with USDMF on PharmaCompass.
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