01 3Mallinckrodt Pharmaceuticals
01 1NOSCAPINE USP SMALL CRYSTALS AND NOSCAPINE HYDROCHLORIDE PURIFIED
02 1NOSCAPINE USP SMALL CRYSTALS CODE 6040 AND NOSCAPINE HYDROCHLORIDE PURIFIED CODE 6150
03 1NOSCAPINE USP/EP CRYSTALS CODE 6047
01 3Ireland
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24157
Submission : 2011-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14626
Submission : 1999-12-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14792
Submission : 1999-12-16
Status : Inactive
Type : II
A Noscapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Noscapine, including repackagers and relabelers. The FDA regulates Noscapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Noscapine 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 Noscapine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Noscapine supplier is an individual or a company that provides Noscapine active pharmaceutical ingredient (API) or Noscapine finished formulations upon request. The Noscapine suppliers may include Noscapine API manufacturers, exporters, distributors and traders.
click here to find a list of Noscapine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Noscapine DMF (Drug Master File) is a document detailing the whole manufacturing process of Noscapine active pharmaceutical ingredient (API) in detail. Different forms of Noscapine DMFs exist exist since differing nations have different regulations, such as Noscapine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Noscapine DMF submitted to regulatory agencies in the US is known as a USDMF. Noscapine USDMF includes data on Noscapine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Noscapine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Noscapine suppliers with USDMF on PharmaCompass.
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