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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PharmaCompass offers a list of Insulin aspart API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Insulin aspart manufacturer or Insulin aspart supplier for your needs.
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PharmaCompass also assists you with knowing the Insulin aspart API Price utilized in the formulation of products. Insulin aspart API Price is not always fixed or binding as the Insulin aspart Price is obtained through a variety of data sources. The Insulin aspart Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Novorapid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Novorapid, including repackagers and relabelers. The FDA regulates Novorapid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Novorapid 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 Novorapid supplier is an individual or a company that provides Novorapid active pharmaceutical ingredient (API) or Novorapid finished formulations upon request. The Novorapid suppliers may include Novorapid API manufacturers, exporters, distributors and traders.
click here to find a list of Novorapid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Novorapid DMF (Drug Master File) is a document detailing the whole manufacturing process of Novorapid active pharmaceutical ingredient (API) in detail. Different forms of Novorapid DMFs exist exist since differing nations have different regulations, such as Novorapid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Novorapid DMF submitted to regulatory agencies in the US is known as a USDMF. Novorapid USDMF includes data on Novorapid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Novorapid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Novorapid suppliers with USDMF on PharmaCompass.
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