Synopsis
Synopsis
0
CEP/COS
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.)
API SUPPLIERS
Click Us!
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 : 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 :
Date of Issue : 2017-11-07
Valid Till : 2020-11-07
Written Confirmation Number : WC-0414
Address of the Firm :
NDC Package Code : 52221-125
Start Marketing Date : 2020-08-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Capital Farma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Parenteral
Solubilizers
Topical
Surfactant & Foaming Agents
Emulsifying Agents
Controlled & Modified Release
Thickeners and Stabilizers
Fillers, Diluents & Binders
Film Formers & Plasticizers
Coating Systems & Additives
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
14
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 TOUJEO SOLOSTAR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TOUJEO SOLOSTAR, including repackagers and relabelers. The FDA regulates TOUJEO SOLOSTAR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TOUJEO SOLOSTAR 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 TOUJEO SOLOSTAR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TOUJEO SOLOSTAR supplier is an individual or a company that provides TOUJEO SOLOSTAR active pharmaceutical ingredient (API) or TOUJEO SOLOSTAR finished formulations upon request. The TOUJEO SOLOSTAR suppliers may include TOUJEO SOLOSTAR API manufacturers, exporters, distributors and traders.
click here to find a list of TOUJEO SOLOSTAR suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TOUJEO SOLOSTAR DMF (Drug Master File) is a document detailing the whole manufacturing process of TOUJEO SOLOSTAR active pharmaceutical ingredient (API) in detail. Different forms of TOUJEO SOLOSTAR DMFs exist exist since differing nations have different regulations, such as TOUJEO SOLOSTAR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TOUJEO SOLOSTAR DMF submitted to regulatory agencies in the US is known as a USDMF. TOUJEO SOLOSTAR USDMF includes data on TOUJEO SOLOSTAR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TOUJEO SOLOSTAR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TOUJEO SOLOSTAR 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 TOUJEO SOLOSTAR Drug Master File in Japan (TOUJEO SOLOSTAR JDMF) empowers TOUJEO SOLOSTAR 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 TOUJEO SOLOSTAR JDMF during the approval evaluation for pharmaceutical products. At the time of TOUJEO SOLOSTAR 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 TOUJEO SOLOSTAR suppliers with JDMF on PharmaCompass.
A TOUJEO SOLOSTAR written confirmation (TOUJEO SOLOSTAR WC) is an official document issued by a regulatory agency to a TOUJEO SOLOSTAR manufacturer, verifying that the manufacturing facility of a TOUJEO SOLOSTAR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TOUJEO SOLOSTAR APIs or TOUJEO SOLOSTAR finished pharmaceutical products to another nation, regulatory agencies frequently require a TOUJEO SOLOSTAR WC (written confirmation) as part of the regulatory process.
click here to find a list of TOUJEO SOLOSTAR 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 TOUJEO SOLOSTAR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TOUJEO SOLOSTAR 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 TOUJEO SOLOSTAR 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 TOUJEO SOLOSTAR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TOUJEO SOLOSTAR NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TOUJEO SOLOSTAR suppliers with NDC on PharmaCompass.
TOUJEO SOLOSTAR 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 TOUJEO SOLOSTAR 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 TOUJEO SOLOSTAR GMP manufacturer or TOUJEO SOLOSTAR GMP API supplier for your needs.
A TOUJEO SOLOSTAR CoA (Certificate of Analysis) is a formal document that attests to TOUJEO SOLOSTAR's compliance with TOUJEO SOLOSTAR specifications and serves as a tool for batch-level quality control.
TOUJEO SOLOSTAR CoA mostly includes findings from lab analyses of a specific batch. For each TOUJEO SOLOSTAR 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.
TOUJEO SOLOSTAR may be tested according to a variety of international standards, such as European Pharmacopoeia (TOUJEO SOLOSTAR EP), TOUJEO SOLOSTAR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TOUJEO SOLOSTAR USP).
