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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.)
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27093
Submission : 2013-05-24
Status : Active
Type : II
Registration Number : 226MF10213
Registrant's Address : Biocon House, Ground Floor, Tower-3, Semicon Park, Electronic City, Phase-II, Hosur Road, Bengaluru-560100
Initial Date of Registration : 2014-11-17
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36695
Submission : 2022-02-16
Status : Active
Type : II
Date of Issue : 2017-11-07
Valid Till : 2020-11-07
Written Confirmation Number : WC-0414
Address of the Firm :
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USDMF
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
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ABOUT THIS PAGE
A Glargine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glargine, including repackagers and relabelers. The FDA regulates Glargine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glargine 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 Glargine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glargine supplier is an individual or a company that provides Glargine active pharmaceutical ingredient (API) or Glargine finished formulations upon request. The Glargine suppliers may include Glargine API manufacturers, exporters, distributors and traders.
click here to find a list of Glargine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glargine DMF (Drug Master File) is a document detailing the whole manufacturing process of Glargine active pharmaceutical ingredient (API) in detail. Different forms of Glargine DMFs exist exist since differing nations have different regulations, such as Glargine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glargine DMF submitted to regulatory agencies in the US is known as a USDMF. Glargine USDMF includes data on Glargine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glargine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glargine 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 Glargine Drug Master File in Japan (Glargine JDMF) empowers Glargine 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 Glargine JDMF during the approval evaluation for pharmaceutical products. At the time of Glargine 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 Glargine suppliers with JDMF on PharmaCompass.
A Glargine written confirmation (Glargine WC) is an official document issued by a regulatory agency to a Glargine manufacturer, verifying that the manufacturing facility of a Glargine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Glargine APIs or Glargine finished pharmaceutical products to another nation, regulatory agencies frequently require a Glargine WC (written confirmation) as part of the regulatory process.
click here to find a list of Glargine suppliers with Written Confirmation (WC) 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 Glargine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glargine 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 Glargine 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 Glargine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glargine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glargine suppliers with NDC on PharmaCompass.
Glargine 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 Glargine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Glargine GMP manufacturer or Glargine GMP API supplier for your needs.
A Glargine CoA (Certificate of Analysis) is a formal document that attests to Glargine's compliance with Glargine specifications and serves as a tool for batch-level quality control.
Glargine CoA mostly includes findings from lab analyses of a specific batch. For each Glargine 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.
Glargine may be tested according to a variety of international standards, such as European Pharmacopoeia (Glargine EP), Glargine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glargine USP).
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