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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
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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
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01 1China
02 3Denmark
03 1Germany
04 1India
05 4U.S.A
06 1Blank
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01 2Active
02 9Inactive
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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
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PharmaCompass offers a list of Insulin 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 manufacturer or Insulin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Insulin manufacturer or Insulin supplier.
PharmaCompass also assists you with knowing the Insulin API Price utilized in the formulation of products. Insulin API Price is not always fixed or binding as the Insulin Price is obtained through a variety of data sources. The Insulin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Afrezza manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Afrezza, including repackagers and relabelers. The FDA regulates Afrezza manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Afrezza 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 Afrezza manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Afrezza supplier is an individual or a company that provides Afrezza active pharmaceutical ingredient (API) or Afrezza finished formulations upon request. The Afrezza suppliers may include Afrezza API manufacturers, exporters, distributors and traders.
click here to find a list of Afrezza suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Afrezza DMF (Drug Master File) is a document detailing the whole manufacturing process of Afrezza active pharmaceutical ingredient (API) in detail. Different forms of Afrezza DMFs exist exist since differing nations have different regulations, such as Afrezza USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Afrezza DMF submitted to regulatory agencies in the US is known as a USDMF. Afrezza USDMF includes data on Afrezza's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Afrezza USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Afrezza suppliers with USDMF on PharmaCompass.
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