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List of Drug Master Files (DMF) of Insulin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Aradigm (1)

02 Bristol Myers Squibb (1)

03 MJ Biopharm Pvt. Ltd. (1)

04 Mannkind (2)

05 Novo Nordisk (3)

06 Yichang Changjiang Pharmaceutical Co., Ltd (1)

07 elm-plastic GmbH (1)

08 Blank (1)

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01 AER INSULIN DIABETES MANAGMENT SYSTEM (1)

02 AFREZZA® INHALATION POWDER AND AFREZZA® INHALER (1)

03 INSULIN (1)

04 INSULIN DRUG SUBSTANCES (1)

05 INSULIN HUMA API (r-DNA ORIGIN) (1)

06 INSULIN HUMAN NON-STERILE BULK DRUG SUBSTANCE (1)

07 INSULIN, HUMAN (RDNA HUMAN INSULIN) HMR 4006 (1)

08 INSULINS, USP--PREPARATION AND PACKAGING, DOSAGE FORMS (1)

09 PRODUCTION OF INSULIN (1)

10 PURIFIED INSULIN (1)

11 SULPHATED INSULIN (1)

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01 China (1)

02 Denmark (3)

03 Germany (1)

04 India (1)

05 U.S.A (4)

06 Blank (1)

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01 Active (2)

02 Inactive (9)

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01 Blank (11)

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13240
Inactive
1998-09-25
N/A
II
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2921
Inactive
1977-05-06
N/A
II
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1713
Inactive
1971-04-28
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28677
Active
2014-10-15
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16482
Inactive
2003-03-26
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34779
Active
2020-04-20
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II
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3536
Inactive
1979-06-14
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5758
Inactive
1985-02-18
N/A
II
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3830
Inactive
1980-05-30
N/A
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NOVO LABORATORIES LTD

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2446
Inactive
1975-05-07
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Looking for 9004-10-8 / Insulin API manufacturers, exporters & distributors?

Insulin manufacturers, exporters & distributors 1

30

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.

API | Excipient name

Insulin

Synonyms

9004-10-8, Iletin, Endopancrine, Decurvon, Dermulin, Humilin

Cas Number

9004-10-8

About Insulin

A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1).

Insulin Manufacturers

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.

Insulin Suppliers

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.

Insulin USDMF

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.

Insulin Manufacturers | Traders | Suppliers

Insulin Manufacturers, Traders, Suppliers 1
24

We have 7 companies offering Insulin

Get in contact with the supplier of your choice:

  1. Aradigm
  2. Bristol Myers Squibb
  3. elm-plastic GmbH
  4. Mannkind
  5. MJ Biopharm Pvt. Ltd.
  6. Novo Nordisk
  7. Yichang Changjiang Pharmaceutical Co., Ltd
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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