01 1Aradigm
02 1Bristol Myers Squibb
03 1MJ Biopharm Pvt. Ltd.
04 2Mannkind
05 3Novo Nordisk
06 1Yichang Changjiang Pharmaceutical Co., Ltd
07 1elm-plastic GmbH
08 1Blank
01 1AER INSULIN DIABETES MANAGMENT SYSTEM
02 1AFREZZA® INHALATION POWDER AND AFREZZA® INHALER
03 1INSULIN
04 1INSULIN DRUG SUBSTANCES
05 1INSULIN HUMA API (r-DNA ORIGIN)
06 1INSULIN HUMAN NON-STERILE BULK DRUG SUBSTANCE
07 1INSULIN, HUMAN (RDNA HUMAN INSULIN) HMR 4006
08 1INSULINS, USP--PREPARATION AND PACKAGING, DOSAGE FORMS
09 1PRODUCTION OF INSULIN
10 1PURIFIED INSULIN
11 1SULPHATED INSULIN
01 1China
02 3Denmark
03 1Germany
04 1India
05 4U.S.A
06 1Blank
01 2Active
02 9Inactive
01 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13240
Submission : 1998-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2921
Submission : 1977-05-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1713
Submission : 1971-04-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28677
Submission : 2014-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16482
Submission : 2003-03-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34779
Submission : 2020-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5758
Submission : 1985-02-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3830
Submission : 1980-05-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3536
Submission : 1979-06-14
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2446
Submission : 1975-05-07
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
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Digital Content
Website
Corporate PDF
A Insulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Insulin, including repackagers and relabelers. The FDA regulates Insulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Insulin 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 Insulin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Insulin supplier is an individual or a company that provides Insulin active pharmaceutical ingredient (API) or Insulin finished formulations upon request. The Insulin suppliers may include Insulin API manufacturers, exporters, distributors and traders.
click here to find a list of Insulin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Insulin DMF (Drug Master File) is a document detailing the whole manufacturing process of Insulin active pharmaceutical ingredient (API) in detail. Different forms of Insulin DMFs exist exist since differing nations have different regulations, such as Insulin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Insulin DMF submitted to regulatory agencies in the US is known as a USDMF. Insulin USDMF includes data on Insulin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Insulin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Insulin suppliers with USDMF on PharmaCompass.
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