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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 Lantus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lantus, including repackagers and relabelers. The FDA regulates Lantus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lantus 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 Lantus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lantus supplier is an individual or a company that provides Lantus active pharmaceutical ingredient (API) or Lantus finished formulations upon request. The Lantus suppliers may include Lantus API manufacturers, exporters, distributors and traders.
click here to find a list of Lantus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lantus DMF (Drug Master File) is a document detailing the whole manufacturing process of Lantus active pharmaceutical ingredient (API) in detail. Different forms of Lantus DMFs exist exist since differing nations have different regulations, such as Lantus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lantus DMF submitted to regulatory agencies in the US is known as a USDMF. Lantus USDMF includes data on Lantus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lantus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lantus 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 Lantus Drug Master File in Japan (Lantus JDMF) empowers Lantus 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 Lantus JDMF during the approval evaluation for pharmaceutical products. At the time of Lantus 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 Lantus suppliers with JDMF on PharmaCompass.
A Lantus written confirmation (Lantus WC) is an official document issued by a regulatory agency to a Lantus manufacturer, verifying that the manufacturing facility of a Lantus active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lantus APIs or Lantus finished pharmaceutical products to another nation, regulatory agencies frequently require a Lantus WC (written confirmation) as part of the regulatory process.
click here to find a list of Lantus 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 Lantus as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lantus 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 Lantus 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 Lantus and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lantus NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lantus suppliers with NDC on PharmaCompass.
Lantus 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 Lantus 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 Lantus GMP manufacturer or Lantus GMP API supplier for your needs.
A Lantus CoA (Certificate of Analysis) is a formal document that attests to Lantus's compliance with Lantus specifications and serves as a tool for batch-level quality control.
Lantus CoA mostly includes findings from lab analyses of a specific batch. For each Lantus 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.
Lantus may be tested according to a variety of international standards, such as European Pharmacopoeia (Lantus EP), Lantus JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lantus USP).
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