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

Client Email

Product

Glargine
Insulin Glargine And Lixisenatide
USDMF

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Glargine

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

5 API Suppliers, 2 USDMF, 1 JDMF, 1 EU WC, 1 NDC API, 2 Listed Suppliers, $ API Reference Price

5 API Suppliers
2 USDMF
1 JDMF
1 EU WC
1 NDC API
2 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

FINISHED DOSAGE FORMULATIONS

68 FDF Dossiers, 10 FDA Orange Book, 34 Europe, 9 Canada, 4 Australia, 10 South Africa, 1 Listed Dossiers

68 FDF Dossiers
10 FDA Orange Book
34 Europe
9 Canada
4 Australia
10 South Africa
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 3 Actylis, 1 BASF, 1 Kerry, 1 Pluviaendo, 2 Seppic

1 Nanjing Well Pharmaceutical
3 Actylis
1 BASF
1 Kerry
1 Pluviaendo
2 Seppic

EXCIPIENTS BY APPLICATIONS

6 Parenteral, 4 Solubilizers, 3 Topical, 2 Surfactant & Foaming Agents, 1 Emulsifying Agents, 1 Controlled & Modified Release, 1 Thickeners and Stabilizers, 1 Film Formers & Plasticizers, 1 Coating Systems & Additives

6 Parenteral
4 Solubilizers
3 Topical
2 Surfactant & Foaming Agents
1 Emulsifying Agents
1 Controlled & Modified Release
1 Thickeners and Stabilizers
1 Film Formers & Plasticizers
1 Coating Systems & Additives

DIGITAL CONTENT

16 DATA COMPILATION #PharmaFlow, 237 NEWS #PharmaBuzz

16 DATA COMPILATION #PharmaFlow
237 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 22 Finished Drug Prices, 31 Annual Reports

6 US Medicaid Prescriptions
22 Finished Drug Prices
31 Annual Reports

MARKET PLACE

7 APIs, 3 FDF Dossiers

7 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

7 Health Canada Patents

7 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 2 USP, 3 JP, 2 Others

1 EDQM
2 USP
3 JP
2 Others

$ API Ref.Price (USD/KG) : 86,245 Xls

Filters

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FILTER :

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2 All

01 1Biocon

02 1Tonghua Dongbao Pharma

filter Subject Reset all filters

2 All

01 1INSULIN GLARGINE

02 1INSULIN GLARGINE (RDNA ORIGIN)

filter Country Reset all filters

2 All

01 1China

02 1India

filter Status Reset all filters

2 All

01 2Active

filter GDUFA DMF Review Reset all filters

2 All

01 2Blank

API Suppliers
USDMF
JDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Biocon Sa

USDMF

Discovery on Target

Not Confirmed

01

Biocon Sa

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Insulin Glargine (rdna Origin)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27093

Submission : 2013-05-24

Status : Active

Type : II

Product Web Link

Digital Content

02

Tonghuadongbao Pharmaceutical Co Ltd

USDMF

Discovery on Target

Not Confirmed

02

Tonghuadongbao Pharmaceutical Co Ltd

Discovery on Target

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

Digital Content

Insulin Glargine

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36695

Submission : 2022-02-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Glargine Manufacturers | Traders | Suppliers

Glargine Manufacturers, Traders, Suppliers 1

30

We have 2 companies offering Glargine

Get in contact with the supplier of your choice:

Biocon
Tonghua Dongbao Pharma

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