01 1Clarochem Ireland
02 2Dasami Lab
03 1Lupin Ltd
04 1MSN Laboratories
05 1Piramal Pharma Solutions
06 1Quimica Sintetica
07 1Sumitomo Pharma
08 1Sun Pharmaceutical Industries Limited
09 1Viatris
01 9DROXIDOPA
02 1DROXIDOPA (PROCESS-II)
01 5India
02 1Ireland
03 1Japan
04 1Spain
05 2U.S.A
01 9Active
02 1Inactive
01 8Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-20
Pay. Date : 2019-01-31
DMF Number : 33459
Submission : 2019-01-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-10
Pay. Date : 2020-11-25
DMF Number : 35368
Submission : 2020-11-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-02
Pay. Date : 2017-11-08
DMF Number : 32184
Submission : 2017-12-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-16
Pay. Date : 2017-10-17
DMF Number : 32032
Submission : 2017-10-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-12
Pay. Date : 2017-10-10
DMF Number : 31514
Submission : 2017-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-25
Pay. Date : 2019-12-31
DMF Number : 34258
Submission : 2019-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-08
Pay. Date : 2017-12-06
DMF Number : 32264
Submission : 2017-11-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20556
Submission : 2007-05-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34389
Submission : 2019-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-15
Pay. Date : 2018-08-22
DMF Number : 33089
Submission : 2018-09-18
Status : Active
Type : II
A Northera manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Northera, including repackagers and relabelers. The FDA regulates Northera manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Northera 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 Northera manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Northera supplier is an individual or a company that provides Northera active pharmaceutical ingredient (API) or Northera finished formulations upon request. The Northera suppliers may include Northera API manufacturers, exporters, distributors and traders.
click here to find a list of Northera suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Northera DMF (Drug Master File) is a document detailing the whole manufacturing process of Northera active pharmaceutical ingredient (API) in detail. Different forms of Northera DMFs exist exist since differing nations have different regulations, such as Northera USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Northera DMF submitted to regulatory agencies in the US is known as a USDMF. Northera USDMF includes data on Northera's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Northera USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Northera suppliers with USDMF on PharmaCompass.
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