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1. 168110-44-9
2. Fr179642
3. Fr-179642
4. Micafungin Fr-179642 Impurity
5. 44677o2tdo
6. Fr-133303
7. Pneumocandin A0, 1-[(4r,5r)-4,5-dihydroxy-l-ornithine]-4-[(4s)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-l-threonine]-
8. [5-[(1s,2s)-2-[(3s,6s,9s,11r,15s,18s,20r,21r,24s,25s,26s)-18-amino-3-[(1r)-3-amino-1-hydroxy-3-oxopropyl]-11,20,21,25-tetrahydroxy-15-[(1r)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-1,4,7,13,16,22-hexazatricyclo[22.3.0.09,13]heptacosan-6-yl]-1,2-dihydroxyethyl]-2-hydroxyphenyl] Hydrogen Sulfate
9. 1-((4r,5r)-4,5-dihydroxy-l-ornithine)-4-((4s)-4-hydroxy-4-(4-hydroxy-3-(sulfooxy)phenyl)-l-threonine)pneumocandin A0
10. Pneumocandin A0, 1-((4r,5r)-4,5-dihydroxy-l-ornithine)-4-((4s)-4-hydroxy-4-(4-hydroxy-3-(sulfooxy)phenyl)-l-threonine)-
11. Pneumocandin A0, 1-((4r,5r)-4,5-dihydroxy-l-ornithine)-4-((s)-4-hydroxy-4-(4-hydroxy-3-(sulfooxy)phenyl)-l-threonine)-
12. Fr 179642
13. Unii-44677o2tdo
14. Schembl14515067
15. Ex-a2749
16. Zinc299872166
17. Hy-129077
18. Cs-0103490
19. 5-((1s,2s)-2-((2r,6s,9s,11r,12r,14as,15s,16s,20s,23s,25as)-9-amino-20-((r)-3-amino-1-hydroxy-3-oxopropyl)-2,11,12,15-tetrahydroxy-6-((r)-1-hydroxyethyl)-16-methyl-5,8,14,19,22,25-hexaoxotetracosahydro-1h-dipyrrolo[2,1-c:2',1'-l][1,4,7,10,13,16]hexaazacyclohenicosin-23-yl)-1,2-dihydroxyethyl)-2-hydroxyphenyl Hydrogen Sulfate
Molecular Weight | 936.9 g/mol |
---|---|
Molecular Formula | C35H52N8O20S |
XLogP3 | -9.3 |
Hydrogen Bond Donor Count | 16 |
Hydrogen Bond Acceptor Count | 21 |
Rotatable Bond Count | 9 |
Exact Mass | 936.30185725 g/mol |
Monoisotopic Mass | 936.30185725 g/mol |
Topological Polar Surface Area | 480 Ų |
Heavy Atom Count | 64 |
Formal Charge | 0 |
Complexity | 1860 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 15 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27434
Submission : 2013-08-29
Status : Active
Type : II
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
About the Company : Zhejiang Huida Biotech Co., Ltd. is located in Hangzhou, Zhejiang Province. It was established in 2020 and is a holding subsidiary of Huadong Medicine Co., Ltd. The company focu...
ABOUT THIS PAGE
A Pneumocandin M1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pneumocandin M1, including repackagers and relabelers. The FDA regulates Pneumocandin M1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pneumocandin M1 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 Pneumocandin M1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pneumocandin M1 supplier is an individual or a company that provides Pneumocandin M1 active pharmaceutical ingredient (API) or Pneumocandin M1 finished formulations upon request. The Pneumocandin M1 suppliers may include Pneumocandin M1 API manufacturers, exporters, distributors and traders.
click here to find a list of Pneumocandin M1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pneumocandin M1 DMF (Drug Master File) is a document detailing the whole manufacturing process of Pneumocandin M1 active pharmaceutical ingredient (API) in detail. Different forms of Pneumocandin M1 DMFs exist exist since differing nations have different regulations, such as Pneumocandin M1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pneumocandin M1 DMF submitted to regulatory agencies in the US is known as a USDMF. Pneumocandin M1 USDMF includes data on Pneumocandin M1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pneumocandin M1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pneumocandin M1 suppliers with USDMF 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 Pneumocandin M1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pneumocandin M1 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 Pneumocandin M1 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 Pneumocandin M1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pneumocandin M1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pneumocandin M1 suppliers with NDC on PharmaCompass.
Pneumocandin M1 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 Pneumocandin M1 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 Pneumocandin M1 GMP manufacturer or Pneumocandin M1 GMP API supplier for your needs.
A Pneumocandin M1 CoA (Certificate of Analysis) is a formal document that attests to Pneumocandin M1's compliance with Pneumocandin M1 specifications and serves as a tool for batch-level quality control.
Pneumocandin M1 CoA mostly includes findings from lab analyses of a specific batch. For each Pneumocandin M1 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.
Pneumocandin M1 may be tested according to a variety of international standards, such as European Pharmacopoeia (Pneumocandin M1 EP), Pneumocandin M1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pneumocandin M1 USP).
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