01 1Amphastar Pharmaceuticals
02 1Novo Excipients
03 1Blank
01 1INSULIN ASPART
02 1INSULIN ASPART USP
03 1NOVOMIX
01 1India
02 1U.S.A
03 1Blank
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32700
Submission : 2018-05-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27184
Submission : 2013-05-15
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39605
Submission : 2024-03-14
Status : Active
Type : II
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A NOVOLOG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NOVOLOG, including repackagers and relabelers. The FDA regulates NOVOLOG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NOVOLOG API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A NOVOLOG supplier is an individual or a company that provides NOVOLOG active pharmaceutical ingredient (API) or NOVOLOG finished formulations upon request. The NOVOLOG suppliers may include NOVOLOG API manufacturers, exporters, distributors and traders.
click here to find a list of NOVOLOG suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A NOVOLOG DMF (Drug Master File) is a document detailing the whole manufacturing process of NOVOLOG active pharmaceutical ingredient (API) in detail. Different forms of NOVOLOG DMFs exist exist since differing nations have different regulations, such as NOVOLOG USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NOVOLOG DMF submitted to regulatory agencies in the US is known as a USDMF. NOVOLOG USDMF includes data on NOVOLOG's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NOVOLOG USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of NOVOLOG suppliers with USDMF on PharmaCompass.
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