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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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PharmaCompass offers a list of Insulin Glargine 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 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.
PharmaCompass also assists you with knowing the Insulin Glargine API Price utilized in the formulation of products. Insulin Glargine API Price is not always fixed or binding as the Insulin Glargine Price is obtained through a variety of data sources. The Insulin Glargine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A A21 Gly B31 Arg B32 Arg insulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of A21 Gly B31 Arg B32 Arg insulin, including repackagers and relabelers. The FDA regulates A21 Gly B31 Arg B32 Arg insulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. A21 Gly B31 Arg B32 Arg 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 A21 Gly B31 Arg B32 Arg insulin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A A21 Gly B31 Arg B32 Arg insulin supplier is an individual or a company that provides A21 Gly B31 Arg B32 Arg insulin active pharmaceutical ingredient (API) or A21 Gly B31 Arg B32 Arg insulin finished formulations upon request. The A21 Gly B31 Arg B32 Arg insulin suppliers may include A21 Gly B31 Arg B32 Arg insulin API manufacturers, exporters, distributors and traders.
click here to find a list of A21 Gly B31 Arg B32 Arg insulin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A A21 Gly B31 Arg B32 Arg insulin DMF (Drug Master File) is a document detailing the whole manufacturing process of A21 Gly B31 Arg B32 Arg insulin active pharmaceutical ingredient (API) in detail. Different forms of A21 Gly B31 Arg B32 Arg insulin DMFs exist exist since differing nations have different regulations, such as A21 Gly B31 Arg B32 Arg insulin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A A21 Gly B31 Arg B32 Arg insulin DMF submitted to regulatory agencies in the US is known as a USDMF. A21 Gly B31 Arg B32 Arg insulin USDMF includes data on A21 Gly B31 Arg B32 Arg insulin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The A21 Gly B31 Arg B32 Arg insulin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of A21 Gly B31 Arg B32 Arg insulin 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 A21 Gly B31 Arg B32 Arg insulin Drug Master File in Japan (A21 Gly B31 Arg B32 Arg insulin JDMF) empowers A21 Gly B31 Arg B32 Arg insulin 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 A21 Gly B31 Arg B32 Arg insulin JDMF during the approval evaluation for pharmaceutical products. At the time of A21 Gly B31 Arg B32 Arg insulin 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 A21 Gly B31 Arg B32 Arg insulin suppliers with JDMF on PharmaCompass.
A A21 Gly B31 Arg B32 Arg insulin written confirmation (A21 Gly B31 Arg B32 Arg insulin WC) is an official document issued by a regulatory agency to a A21 Gly B31 Arg B32 Arg insulin manufacturer, verifying that the manufacturing facility of a A21 Gly B31 Arg B32 Arg insulin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting A21 Gly B31 Arg B32 Arg insulin APIs or A21 Gly B31 Arg B32 Arg insulin finished pharmaceutical products to another nation, regulatory agencies frequently require a A21 Gly B31 Arg B32 Arg insulin WC (written confirmation) as part of the regulatory process.
click here to find a list of A21 Gly B31 Arg B32 Arg insulin 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 A21 Gly B31 Arg B32 Arg insulin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for A21 Gly B31 Arg B32 Arg insulin 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 A21 Gly B31 Arg B32 Arg insulin 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 A21 Gly B31 Arg B32 Arg insulin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a A21 Gly B31 Arg B32 Arg insulin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of A21 Gly B31 Arg B32 Arg insulin suppliers with NDC on PharmaCompass.
A21 Gly B31 Arg B32 Arg insulin 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 A21 Gly B31 Arg B32 Arg insulin 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 A21 Gly B31 Arg B32 Arg insulin GMP manufacturer or A21 Gly B31 Arg B32 Arg insulin GMP API supplier for your needs.
A A21 Gly B31 Arg B32 Arg insulin CoA (Certificate of Analysis) is a formal document that attests to A21 Gly B31 Arg B32 Arg insulin's compliance with A21 Gly B31 Arg B32 Arg insulin specifications and serves as a tool for batch-level quality control.
A21 Gly B31 Arg B32 Arg insulin CoA mostly includes findings from lab analyses of a specific batch. For each A21 Gly B31 Arg B32 Arg insulin 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.
A21 Gly B31 Arg B32 Arg insulin may be tested according to a variety of international standards, such as European Pharmacopoeia (A21 Gly B31 Arg B32 Arg insulin EP), A21 Gly B31 Arg B32 Arg insulin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (A21 Gly B31 Arg B32 Arg insulin USP).
