Synopsis
Synopsis
0
CEP/COS
0
EU WC
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers


1. 901, Hoe
2. A21 Gly B31 Arg B32 Arg Insulin
3. A21-gly-b31-arg-b32-arg-insulin
4. Basaglar
5. Glargine
6. Glargine, Insulin
7. Glargine-aglr, Insulin
8. Hoe 901
9. Hoe-901
10. Hoe901
11. Insulin Glargine
12. Insulin Glargine-aglr
13. Insulin Glargine-yfgn
14. Insulin, Gly(a21)-arg(b31,b32)
15. Insulin, Glycyl(a21)-arginyl(b31,b32)
16. Lantus
17. Lantus Solostar
18. Rezvoglar
19. Semglee
20. Solostar, Lantus
1. Gtpl7572
2. Hoe901
3. Hoe-901
| Molecular Weight | 6063 g/mol |
|---|---|
| Molecular Formula | C267H404N72O78S6 |
| XLogP3 | -14.1 |
| Hydrogen Bond Donor Count | 85 |
| Hydrogen Bond Acceptor Count | 92 |
| Rotatable Bond Count | 191 |
| Exact Mass | 6060.8251182 g/mol |
| Monoisotopic Mass | 6058.8184085 g/mol |
| Topological Polar Surface Area | 2590 Ų |
| Heavy Atom Count | 423 |
| Formal Charge | 0 |
| Complexity | 15300 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 53 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Lantus |
| PubMed Health | Insulin Glargine |
| Drug Classes | Antidiabetic, Insulin, Long Acting |
| Drug Label | LANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenter... |
| Active Ingredient | Insulin glargine recombinant |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 100 units/ml |
| Market Status | Prescription |
| Company | Sanofi Aventis Us |
| 2 of 2 | |
|---|---|
| Drug Name | Lantus |
| PubMed Health | Insulin Glargine |
| Drug Classes | Antidiabetic, Insulin, Long Acting |
| Drug Label | LANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenter... |
| Active Ingredient | Insulin glargine recombinant |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 100 units/ml |
| Market Status | Prescription |
| Company | Sanofi Aventis Us |
Hypoglycemic Agents
Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27093
Submission : 2013-05-24
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36695
Submission : 2022-02-16
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41930
Submission : 2025-05-21
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Insulin glargine (recombinant)
Registration Number : 226MF10213
Registrant's Address : Biocon House, Ground Floor, Tower-3, Semicon Park, Electronic City, Phase-II, Hosur R...
Initial Date of Registration : 2014-11-17
Latest Date of Registration : 2019-01-24

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 52221-125
Start Marketing Date : 2020-08-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 65727-023
Start Marketing Date : 2005-01-01
End Marketing Date : 2026-06-30
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 85893-002
Start Marketing Date : 2025-10-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : Established in 1997, Nanogen Pharmaceutical Biotechnology JSC has been striving to become a world-class innovative biotechnology company in the pharmaceutical industry. We are pro...

About the Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom synthesis and manufact...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Glargine,Lixisenatide
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 04, 2024
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
December 04, 2024
Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Glargine,Lixisenatide
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 04, 2024
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
iGlarLixi CGM Study in Chinese T2D Individuals After OADs
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
November 04, 2024
Details:
Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.
Lead Product(s): Insulin Glargine,Lixisenatide
Therapeutic Area: Endocrinology Brand Name: Soliqua
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 27, 2023
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Sanofi Launches New Long-Acting Insulin Drug in India
Details : Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.
Product Name : Soliqua
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
March 27, 2023
Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Glargine,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Peptide, Unconjugated
Sponsor: Mira Zuidgeest
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 22, 2023
Lead Product(s) : Insulin Glargine,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Mira Zuidgeest
Deal Size : Inapplicable
Deal Type : Inapplicable
Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
March 22, 2023
Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Glargine,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 23, 2022
Lead Product(s) : Insulin Glargine,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
September 23, 2022
Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Glargine,Lixisenatide,Metformin
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 10, 2022
Lead Product(s) : Insulin Glargine,Lixisenatide,Metformin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
June 10, 2022
Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Glargine,Lixisenatide
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 10, 2021
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
November 10, 2021
Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Glargine,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 12, 2021
Lead Product(s) : Insulin Glargine,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
August 12, 2021
Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Glargine,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 28, 2021
Lead Product(s) : Insulin Glargine,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve P...
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
July 28, 2021
Details:
Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.
Lead Product(s): Insulin Glargine,Lixisenatide
Therapeutic Area: Endocrinology Brand Name: Soliqua
Study Phase: UndisclosedProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 28, 2021
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
New Soliqua® Data Shows Improved Blood Sugar Control Without Weight Gain Versus Premixed Insulin
Details : Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.
Product Name : Soliqua
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
June 28, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus Optiset
Dosage Form : Injectable Solution
Dosage Strength : 100 U/ml
Packaging :
Approval Date : 06-02-2001
Application Number : 28103247201
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus Solostar
Dosage Form : Solution For Injection
Dosage Strength : 100 U/ml
Packaging :
Approval Date : 01-09-2006
Application Number : 28104219807
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus
Dosage Form : Injection Solution
Dosage Strength : 100 units/ml
Packaging :
Approval Date : 09-06-2000
Application Number : 28103089899
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus
Dosage Form : Solution For Injection
Dosage Strength : 100 units/ml
Packaging :
Approval Date : 09-06-2000
Application Number : 28103065399
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus Opticlik
Dosage Form : Solution For Injection
Dosage Strength : 100 units/ml
Packaging :
Approval Date : 31-08-2004
Application Number : 28103637404
Regulatory Info : Prescription
Registration Country : Denmark
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : USA
Brand Name : LANTUS
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 100 UNITS/ML
Packaging :
Approval Date :
Application Number : 21081
Regulatory Info :
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : USA
Brand Name : LANTUS SOLOSTAR
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 300 UNITS/3ML (100 UNITS/ML)
Packaging :
Approval Date :
Application Number : 21081
Regulatory Info :
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : USA
Brand Name : TOUJEO SOLOSTAR
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 450 UNITS/1.5ML (300 UNITS/ML)
Packaging :
Approval Date :
Application Number : 206538
Regulatory Info :
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : USA
Brand Name : TOUJEO MAX SOLOSTAR
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 900 UNITS/3ML (300 UNITS/ML)
Packaging :
Approval Date :
Application Number : 206538
Regulatory Info :
Registration Country : USA
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : USA
INSULIN GLARGINE; LIXISENATIDE
Brand Name : SOLIQUA 100/33
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML)
Packaging :
Approval Date :
Application Number : 208673
Regulatory Info :
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus Optiset
Dosage Form : Injectable Solution
Dosage Strength : 100 U/ml
Packaging :
Approval Date : 06-02-2001
Application Number : 28103247201
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus Solostar
Dosage Form : Solution For Injection
Dosage Strength : 100 U/ml
Packaging :
Approval Date : 01-09-2006
Application Number : 28104219807
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus
Dosage Form : Injection Solution
Dosage Strength : 100 units/ml
Packaging :
Approval Date : 09-06-2000
Application Number : 28103089899
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus
Dosage Form : Solution For Injection
Dosage Strength : 100 units/ml
Packaging :
Approval Date : 09-06-2000
Application Number : 28103065399
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lantus Opticlik
Dosage Form : Solution For Injection
Dosage Strength : 100 units/ml
Packaging :
Approval Date : 31-08-2004
Application Number : 28103637404
Regulatory Info : Prescription
Registration Country : Denmark
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Lantus
Dosage Form : Insulin Glargine 1.000Iu 10Ml 1 Units Parenteral Use
Dosage Strength : 1 vial SC 1,000 IU 10 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Lantus
Dosage Form : Injectable Solution In Cartridge
Dosage Strength : 3.6378mg/ml
Packaging :
Approval Date : 16/05/2002
Application Number : 55346
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Toujeo
Dosage Form : Solostar Injectable Solution In Pre-Filled Pen
Dosage Strength : 300UNIT
Packaging :
Approval Date : 11-05-2015
Application Number : 100133034
Regulatory Info : Authorized
Registration Country : Spain
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Suliqua
Dosage Form : Solution For Injection
Dosage Strength : 100IU/ml; 50mcg/ml
Packaging :
Approval Date : 11-01-2017
Application Number : 28105754016
Regulatory Info : Prescription
Registration Country : Denmark
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Lantus
Dosage Form : Injectable Solution
Dosage Strength : 100units/ml
Packaging :
Approval Date : 09-06-2000
Application Number : 2.00E+13
Regulatory Info : Approved
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Excipients by Applications
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
97
PharmaCompass offers a list of Insulin Glargine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Insulin Glargine manufacturer or Insulin Glargine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Insulin Glargine manufacturer or Insulin Glargine supplier.
A BASAGLAR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BASAGLAR, including repackagers and relabelers. The FDA regulates BASAGLAR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BASAGLAR 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 BASAGLAR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A BASAGLAR supplier is an individual or a company that provides BASAGLAR active pharmaceutical ingredient (API) or BASAGLAR finished formulations upon request. The BASAGLAR suppliers may include BASAGLAR API manufacturers, exporters, distributors and traders.
click here to find a list of BASAGLAR suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A BASAGLAR DMF (Drug Master File) is a document detailing the whole manufacturing process of BASAGLAR active pharmaceutical ingredient (API) in detail. Different forms of BASAGLAR DMFs exist exist since differing nations have different regulations, such as BASAGLAR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BASAGLAR DMF submitted to regulatory agencies in the US is known as a USDMF. BASAGLAR USDMF includes data on BASAGLAR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BASAGLAR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BASAGLAR suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The BASAGLAR Drug Master File in Japan (BASAGLAR JDMF) empowers BASAGLAR API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the BASAGLAR JDMF during the approval evaluation for pharmaceutical products. At the time of BASAGLAR JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of BASAGLAR suppliers with JDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing BASAGLAR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BASAGLAR API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture BASAGLAR as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain BASAGLAR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BASAGLAR NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BASAGLAR suppliers with NDC on PharmaCompass.
BASAGLAR Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of BASAGLAR GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right BASAGLAR GMP manufacturer or BASAGLAR GMP API supplier for your needs.
A BASAGLAR CoA (Certificate of Analysis) is a formal document that attests to BASAGLAR's compliance with BASAGLAR specifications and serves as a tool for batch-level quality control.
BASAGLAR CoA mostly includes findings from lab analyses of a specific batch. For each BASAGLAR CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
BASAGLAR may be tested according to a variety of international standards, such as European Pharmacopoeia (BASAGLAR EP), BASAGLAR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BASAGLAR USP).