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Chemistry

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Also known as: Indocyanine green, 3599-32-4, Cardio-green, Foxgreen, Mfcd00013078, Sodium;4-[(2e)-2-[(2e,4e,6e)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium-2-yl]hepta-2,4,6-trienylidene]-1,1-dimethylbenzo[e]indol-3-yl]butane-1-sulfonate
Molecular Formula
C43H47N2NaO6S2
Molecular Weight
775.0  g/mol
InChI Key
MOFVSTNWEDAEEK-UHFFFAOYSA-M

Indocyanine Green
A tricarbocyanine dye that is used diagnostically in liver function tests and to determine blood volume and cardiac output.
1 2D Structure

Indocyanine Green

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;4-[(2E)-2-[(2E,4E,6E)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium-2-yl]hepta-2,4,6-trienylidene]-1,1-dimethylbenzo[e]indol-3-yl]butane-1-sulfonate
2.1.2 InChI
InChI=1S/C43H48N2O6S2.Na/c1-42(2)38(44(28-14-16-30-52(46,47)48)36-26-24-32-18-10-12-20-34(32)40(36)42)22-8-6-5-7-9-23-39-43(3,4)41-35-21-13-11-19-33(35)25-27-37(41)45(39)29-15-17-31-53(49,50)51;/h5-13,18-27H,14-17,28-31H2,1-4H3,(H-,46,47,48,49,50,51);/q;+1/p-1
2.1.3 InChI Key
MOFVSTNWEDAEEK-UHFFFAOYSA-M
2.1.4 Canonical SMILES
CC1(C(=[N+](C2=C1C3=CC=CC=C3C=C2)CCCCS(=O)(=O)[O-])C=CC=CC=CC=C4C(C5=C(N4CCCCS(=O)(=O)[O-])C=CC6=CC=CC=C65)(C)C)C.[Na+]
2.1.5 Isomeric SMILES
CC1(C(=[N+](C2=C1C3=CC=CC=C3C=C2)CCCCS(=O)(=O)[O-])/C=C/C=C/C=C/C=C/4\C(C5=C(N4CCCCS(=O)(=O)[O-])C=CC6=CC=CC=C65)(C)C)C.[Na+]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Cardio Green

2. Cardio-green

3. Green, Indocyanine

4. Indocyanine Green

5. Ujoveridin

6. Vofaverdin

7. Vophaverdin

8. Wofaverdin

2.2.2 Depositor-Supplied Synonyms

1. Indocyanine Green

2. 3599-32-4

3. Cardio-green

4. Foxgreen

5. Mfcd00013078

6. Sodium;4-[(2e)-2-[(2e,4e,6e)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium-2-yl]hepta-2,4,6-trienylidene]-1,1-dimethylbenzo[e]indol-3-yl]butane-1-sulfonate

7. Indocyaninegreen

8. Sodium 4-(2-(7-(1,1-dimethyl-3-(4-sulfonatobutyl)-1h-benzo[e]indol-2(3h)-ylidene)hepta-1,3,5-trien-1-yl)-1,1-dimethyl-1h-benzo[e]indol-3-ium-3-yl)butane-1-sulfonate

9. 1h-benz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2h-benz[e]indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, Inner Salt, Sodium Salt

10. Cardiogreen, For Microscopy

11. Cardiogreen, Polymethine Dye

12. Schembl16027582

13. Akos015896404

14. Akos016010308

15. As-11023

16. I0535

17. A823083

18. Q905662

19. Indocyanine Green, United States Pharmacopeia (usp) Reference Standard

20. Sodium 4-[(2e)-2-[(2e,4e,6e)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)-2-benzo[e]indol-3-iumyl]hepta-2,4,6-trienylidene]-1,1-dimethyl-3-benzo[e]indolyl]-1-butanesulfonate

21. Sodium 4-[(2e)-2-[(2e,4e,6e)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium-2-yl]hepta-2,4,6-trienylidene]-1,1-dimethyl-benzo[e]indol-3-yl]butane-1-sulfonate

2.3 Create Date
2006-12-24
3 Chemical and Physical Properties
Molecular Weight 775.0 g/mol
Molecular Formula C43H47N2NaO6S2
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count7
Rotatable Bond Count12
Exact Mass774.27732385 g/mol
Monoisotopic Mass774.27732385 g/mol
Topological Polar Surface Area137 Ų
Heavy Atom Count54
Formal Charge0
Complexity1520
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count4
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameIc-green
Drug LabelICGREEN is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Aqueous Solvent consisting of Sterile Water for Injection used to dissolve the indocyanine green. IC...
Active IngredientIndocyanine green
Dosage FormInjectable
RouteInjection
Strength25mg/vial
Market StatusPrescription
CompanyAkorn

2 of 4  
Drug NameIndocyanine green
Drug LabelICGREEN is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Aqueous Solvent consisting of Sterile Water for Injection used to dissolve the indocyanine green. IC...
Active IngredientIndocyanine green
Dosage FormInjectable
RouteInjection
Strength25mg/vial
Market StatusPrescription
CompanyPulsion Medcl

3 of 4  
Drug NameIc-green
Drug LabelICGREEN is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Aqueous Solvent consisting of Sterile Water for Injection used to dissolve the indocyanine green. IC...
Active IngredientIndocyanine green
Dosage FormInjectable
RouteInjection
Strength25mg/vial
Market StatusPrescription
CompanyAkorn

4 of 4  
Drug NameIndocyanine green
Drug LabelICGREEN is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. It is packaged with Aqueous Solvent consisting of Sterile Water for Injection used to dissolve the indocyanine green. IC...
Active IngredientIndocyanine green
Dosage FormInjectable
RouteInjection
Strength25mg/vial
Market StatusPrescription
CompanyPulsion Medcl

4.2 Therapeutic Uses

Dyes

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


TO DETERMINE CARDIAC OUTPUT, HEPATIC FUNCTION, & LIVER BLOOD FLOW. FOR HEPATIC FUNCTION STUDIES, CALCULATED AMT OF DIAGNOSTIC AGENT IS INJECTED INTO ARM VEIN. 20 MIN AFTER INJECTION, 6 ML OF VENOUS BLOOD IS WITHDRAWN FROM OPPOSITE ARM. AFTER COAGULATION & CENTRIFUGATION, CLEAR SERUM IS READ IN PHOTOMETER @ 800-810 NM.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1214


DYE RETENTION OF LESS THAN 4% IS FOUND IN HEALTHY SUBJECTS. ... FAILURE TO REMOVE DYE, AS INDICATED BY SERUM LEVELS IN EXCESS OF 4%, IS INDICATIVE OF IMPAIRED HEPATIC FUNCTION.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1214


USUAL, IV, BLOOD VOL DETERMINATION, 5 MG IN 1 ML; HEPATIC FUNCTION DETERMINATION, 0-5 MG/KG.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1214


DYE IS STABLE IN PLASMA & WHOLE BLOOD PERMITTING LATER ANALYSIS. USERS VARY BOTH CONCN & DOSAGE. IN MAN TOTAL DOSAGE HAS NORMALLY BEEN BELOW 2 MG/KG.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 275


4.3 Drug Warning

...CONTAINS SMALL AMT OF /5%/ SODIUM IODIDE; THUS, IT SHOULD BE USED WITH CAUTION IN PT ALLERGIC TO IODIDES & RADIOACTIVE IODINE UPTAKE STUDIES SHOULD NOT BE PERFORMED FOR AT LEAST 1 WK FOLLOWING ITS USE. SINCE PROBENECID HAS BEEN SHOWN IN DOGS TO AFFECT HEPATIC UPTAKE, THIS POSSIBILITY SHOULD BE KEPT IN MIND.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1214


SAFE USE OF THIS DRUG IN PREGNANCY HAS NOT BEEN ESTABLISHED.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1214


USE FRESH SOLN ONLY AS RECOMMENDED.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 275


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Coloring Agents

Chemicals and substances that impart color including soluble dyes and insoluble pigments. They are used in INKS; PAINTS; and as INDICATORS AND REAGENTS. (See all compounds classified as Coloring Agents.)


5.2 ATC Code

V - Various

V04 - Diagnostic agents

V04C - Other diagnostic agents

V04CX - Other diagnostic agents

V04CX01 - Indocyanine green


5.3 Absorption, Distribution and Excretion

FOLLOWING IV INJECTION, INDOCYANINE GREEN IS RAPIDLY BOUND TO PLASMA PROTEIN, QUICKLY REMOVED FROM CIRCULATION BY LIVER, & EXCRETED IN BILE IN UNCONJUGATED FORM.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1214


WITH INDOCYANINE GREEN, IT HAS BEEN SHOWN THAT RAT HAS HIGHER MAX BILIARY EXCRETION RATE (0.065 MG/KG/MIN) THAN DOES RABBIT (0.05 MG/KG/MIN) OR DOG (0.027 MG/KG/MIN).

LaDu, B.N., H.G. Mandel, and E.L. Way. Fundamentals of Drug Metabolism and Disposition. Baltimore: Williams and Wilkins, 1971., p. 139


T/2 INCR WITH INCR DOSAGE. ... CONSIDERABLE DIFFERENCE HAS BEEN NOTED BETWEEN NORMAL MONGRELS & PUREBRED BEAGLES IN CLEARANCE TIMES.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 275


APPARENT HEPATIC EXTRACTION OF INDOCYANINE GREEN IN RATS WAS SURPRISINGLY LOW @ DOSES ABOVE 1 MG/KG. CHANGES IN HEPATIC BLOOD FLOW WOULD NOT ALTER CLEARANCE.

PMID:512932 IGA T, KLAASSEN CD; J PHARMACOL EXP THER 211 (3): 690 (1979)


For more Absorption, Distribution and Excretion (Complete) data for INDOCYANINE GREEN (10 total), please visit the HSDB record page.


5.4 Metabolism/Metabolites

...INDOCYANINE GREEN...APPEARS IN BILE UNCHANGED

Patty, F. (ed.). Industrial Hygiene and Toxicology: Volume II: Toxicology. 2nd ed. New York: Interscience Publishers, 1963., p. 436


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Biophore India Pharmaceuticals Pvt...

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Kinsy SL

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Macsen Drugs

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 40164

Submission : 2024-06-27

Status : Active

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HL Genomics

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indocyanine green

Registrant Name : H.L.G.Nomics Co., Ltd.

Registration Date : 2019-10-23

Registration Number : 20191023-210-J-461

Manufacturer Name : H.L.G.Nomics Co., Ltd.

Manufacturer Address : 1552 Bogaewonsam-ro, Wonsam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do

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INDOCYANINE GREEN

NDC Package Code : 69575-4052

Start Marketing Date : 2021-12-17

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (25kg/25kg)

Marketing Category : BULK INGREDIENT

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INDOCYANINE GREEN

NDC Package Code : 68225-110

Start Marketing Date : 2019-09-10

End Marketing Date : 2025-12-31

Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (25mg/mL)

Marketing Category : DRUG FOR FURTHER PROCESSING

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INDOCYANINE GREEN

NDC Package Code : 58272-202

Start Marketing Date : 2009-01-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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Macsen Labs

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Indocyanine Green

About the Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our c...

Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our comprehensive offerings extend to Contract Research & Custom Synthesis. With a legacy of over seven decades, Macsen combines tradition with innovation to meet the evolving needs of the chemical and pharmaceutical sectors. Our commitment to quality is evident in every aspect of our operations, from state-of-the-art manufacturing facilities to advanced analytical capabilities.
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Indocyanine Green

About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.
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Indocyanine Green

About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
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Kinsy SL

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Indocyanine Green

About the Company : Kinsy, an independent CDMO in Spain, offers over 30 years of expertise in developing and manufacturing advanced pharmaceutical intermediates and APIs. We provide innovative route d...

Kinsy, an independent CDMO in Spain, offers over 30 years of expertise in developing and manufacturing advanced pharmaceutical intermediates and APIs. We provide innovative route development, analytical method optimization, pilot plant scale-up, and clinical-phase production with advanced purification techniques. Our services include process validation, commercial-scale manufacturing (>100 MT/year), and regulatory support (DMF, CEP, REACH). ISO 9001-certified and operating under cGMP standards audited by AEMPS, we are a trusted partner to leading global pharmaceutical companies.
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Indocyanine Green

About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...

Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine chemicals and fundamental chemical materials. It has an efficient research and development team. Beijing Mesochem provides its customers customized development, craft optimization, contract customization and outsourcing services. The company has a well-established industrial base in Weinan, Shanxi Province. The production base features a 20,000 ㎡ plant with a production capacity of over 8,000 MT per year.
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Indocyanine Green

About the Company : We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to m...

We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to market while improving the lives of their patients across the world. Our objective is to help our customers create a better world as the partner of choice to develop and manufacture complex and challenging substances, highly potent active ingredients, and breaking new ground with innovative vitamin, healthcare, and industrial products.
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Icrom

Italy
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Icrom

Italy
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Indocyanine Green

About the Company : ICROM is specialized in the manufacturing and contract manufacturing of Active Pharmaceutical Ingredients (APIs) and GMP intermediates. ICROM is the partner of choice for pharmaceu...

ICROM is specialized in the manufacturing and contract manufacturing of Active Pharmaceutical Ingredients (APIs) and GMP intermediates. ICROM is the partner of choice for pharmaceutical outsourcing. Since 1969, ICROM is specialized in the manufacturing and contract manufacturing of Active Pharmaceutical Ingredients (APIs) and GMP intermediates. Thanks to the extensive experience and strong know-how, ICROM is the ideal partner for designing and tailoring projects upon customers’ needs.
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Indocyanine Green

About the Company : Nantong Jinghua Pharmaceutical is a public pharmaceutical company that was established in 1957, owns about 302 staff, located in No. 20, 3 Haibin Road, Yanhai Economic Development ...

Nantong Jinghua Pharmaceutical is a public pharmaceutical company that was established in 1957, owns about 302 staff, located in No. 20, 3 Haibin Road, Yanhai Economic Development Zone, Rudong, Nantong, Jiangsu, China. They are appointed as a high-new-technical enterprise by Jiangsu Scientific Technological Bureau. As a comprehensive, advanced, and innovative GMP company, they focus on the manufacture, R&D, and sales of APIs and pharmaceutical intermediates. The Company produces Phenobarbital, Primidone, Fluorouracil, Phenylbutazone, Flucytosine, Piroxicam, Propylthiouracil, etc., in which the first five products have CEP certificates.
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Indocyanine Green

About the Company : Research Directions is a Brisbane based company working in a global industry supplying specialty chemicals that are manufactured in our laboratory.These specialty chemicals include...

Research Directions is a Brisbane based company working in a global industry supplying specialty chemicals that are manufactured in our laboratory.These specialty chemicals include analytical standards for diagnosis of disease, pheromones for use in the monitoring of insects and active pharmaceutical ingredients. We are a small group of highly skilled synthetic organic chemists with many years of experience in the development of synthetic methods for specialty chemicals that may not be available or that may require a more efficient method of production.
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API Reference Price

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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"UNITED STATES PHARMACOPEIAL CONVENTION","supplierCountry":"FINLAND","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0015","unit":"KGS","unitRateFc":"131340","totalValueFC":"204.4","currency":"USD","unitRateINR":"10280433.3","date":"13-Apr-2022","totalValueINR":"15420.65","totalValueInUsd":"204.4","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"8264612","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"}]
13-Apr-2022
19-Jun-2025
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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMacsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.

CAS Number : 1497-49-0

End Use API : Indocyanine Green

About The Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty F...

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02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMacsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.

CAS Number : 63149-24-6

End Use API : Indocyanine Green

About The Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty F...

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03

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CAS Number : 1633-83-6

End Use API : Indocyanine Green

About The Company : Anvitha Life Care Private Limited, founded in 2016 by Dr. T. Prakasam and a team of experienced scientists and technocrats with over 80 years of combined expert...

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CAS Number : 1633-83-6

End Use API : Indocyanine Green

About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

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05

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CAS Number : 216-647-9

End Use API : Indocyanine Green

About The Company : Novick Bio-Sciences is a rapidly-growing Contract Research and Development Organization (CRDO) providing chemistry and formulation development services to Globa...

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FDA Orange Book

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01

RENEW PHARMS

U.S.A
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RENEW PHARMS

U.S.A
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INDOCYANINE GREEN

Brand Name : IC-GREEN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 25MG/VIAL

Approval Date : 1982-01-01

Application Number : 11525

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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02

RENEW PHARMS

U.S.A
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RENEW PHARMS

U.S.A
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INDOCYANINE GREEN

Brand Name : IC-GREEN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 11525

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

RENEW PHARMS

U.S.A
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RENEW PHARMS

U.S.A
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INDOCYANINE GREEN

Brand Name : IC-GREEN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 11525

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

RENEW PHARMS

U.S.A
AGGSpend
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RENEW PHARMS

U.S.A
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INDOCYANINE GREEN

Brand Name : IC-GREEN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 11525

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

RENEW PHARMS

U.S.A
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RENEW PHARMS

U.S.A
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INDOCYANINE GREEN

Brand Name : INDOCYANINE GREEN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 25MG/VIAL

Approval Date : 2007-11-21

Application Number : 40811

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

NOVADAQ TECH

U.S.A
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NOVADAQ TECH

U.S.A
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INDOCYANINE GREEN

Brand Name : SPY AGENT GREEN KIT

Dosage Form : POWDER;INTRAVENOUS, INTERSTITIAL

Dosage Strength : 25MG/VIAL

Approval Date : 2018-11-21

Application Number : 211580

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Europe

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01

PULSION Medical Systems SE

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Indocyanine Green

Brand Name : indocyanine green Pulsion

Dosage Form : POWDER FOR SOLUTION FOR INJECTION

Dosage Strength : -

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Canada

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01

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INDOCYANINE GREEN

Brand Name : SPY AGENT GREEN

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 25MG/VIAL

Packaging :

Approval Date :

Application Number : 2483653

Regulatory Info :

Registration Country : Canada

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INDOCYANINE GREEN

Brand Name : SPY AGENT GREEN KIT FOR SPY ELITE

Dosage Form : KIT

Dosage Strength : 25MG/VIAL

Packaging :

Approval Date :

Application Number : 2483661

Regulatory Info :

Registration Country : Canada

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INDOCYANINE GREEN

Brand Name : SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 25MG/VIAL

Packaging :

Approval Date :

Application Number : 2483688

Regulatory Info :

Registration Country : Canada

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INDOCYANINE GREEN

Brand Name : SPY AGENT GREEN LYMPHATICS KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 25MG/VIAL

Packaging :

Approval Date :

Application Number : 2483696

Regulatory Info :

Registration Country : Canada

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05

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INDOCYANINE GREEN

Brand Name : SPY AGENT GREEN KIT FOR SPY-PHI

Dosage Form : KIT

Dosage Strength : 25MG/VIAL

Packaging :

Approval Date :

Application Number : 2498677

Regulatory Info :

Registration Country : Canada

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INDOCYANINE GREEN

Brand Name : SPY AGENT GREEN KIT FOR ADVANCED IMAGING MODALITY (AIM) AND PINPOINT

Dosage Form : KIT

Dosage Strength : 25MG/VIAL

Packaging :

Approval Date :

Application Number : 2527839

Regulatory Info :

Registration Country : Canada

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DIAGNOSTIC GREEN LIMITED

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DIAGNOSTIC GREEN LIMITED

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INDOCYANINE GREEN

Brand Name : INDOCYANINE GREEN FOR INJECTION, USP

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 25MG/VIAL

Packaging :

Approval Date :

Application Number : 2485796

Regulatory Info :

Registration Country : Canada

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DATA COMPILATION #PharmaFlow

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DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions
Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   

Impressions: 8045

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

#PharmaFlow by PHARMACOMPASS
24 Oct 2024

NEWS #PharmaBuzz

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APIs

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Patents & EXCLUSIVITIES

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US Patents

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01

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NOVADAQ TECH

U.S.A
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INDOCYANINE GREEN

US Patent Number : 8647605

Drug Substance Claim :

Drug Product Claim :

Application Number : 211580

Patent Use Code : U-2468

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-02-11

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NOVADAQ TECH

U.S.A
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INDOCYANINE GREEN

US Patent Number : 11712320

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 211580

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-07-14

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NOVADAQ TECH

U.S.A
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INDOCYANINE GREEN

US Patent Number : 10631746

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 211580

Patent Use Code : U-2815

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-08-04

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INDOCYANINE GREEN

US Patent Number : 8647605

Drug Substance Claim :

Drug Product Claim :

Application Number : 211580

Patent Use Code : U-2464

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-02-11

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INDOCYANINE GREEN

US Patent Number : 9421280

Drug Substance Claim :

Drug Product Claim :

Application Number : 211580

Patent Use Code : U-2467

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-11-24

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INDOCYANINE GREEN

US Patent Number : 8185176

Drug Substance Claim :

Drug Product Claim :

Application Number : 211580

Patent Use Code : U-2462

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-06-04

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INDOCYANINE GREEN

US Patent Number : 8406860

Drug Substance Claim :

Drug Product Claim :

Application Number : 211580

Patent Use Code : U-2463

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-04-09

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INDOCYANINE GREEN

US Patent Number : 9421280

Drug Substance Claim :

Drug Product Claim :

Application Number : 211580

Patent Use Code : U-2466

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-11-24

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Looking for 3599-32-4 / Indocyanine Green API manufacturers, exporters & distributors?

Indocyanine Green manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Indocyanine Green 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 Indocyanine Green manufacturer or Indocyanine Green supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Indocyanine Green manufacturer or Indocyanine Green supplier.

PharmaCompass also assists you with knowing the Indocyanine Green API Price utilized in the formulation of products. Indocyanine Green API Price is not always fixed or binding as the Indocyanine Green Price is obtained through a variety of data sources. The Indocyanine Green Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Indocyanine Green

Synonyms

3599-32-4, Cardio-green, Foxgreen, Mfcd00013078, Sodium;4-[(2e)-2-[(2e,4e,6e)-7-[1,1-dimethyl-3-(4-sulfonatobutyl)benzo[e]indol-3-ium-2-yl]hepta-2,4,6-trienylidene]-1,1-dimethylbenzo[e]indol-3-yl]butane-1-sulfonate, Indocyaninegreen

Cas Number

3599-32-4

About Indocyanine Green

A tricarbocyanine dye that is used diagnostically in liver function tests and to determine blood volume and cardiac output.

Indocyanine Green Manufacturers

A Indocyanine Green manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indocyanine Green, including repackagers and relabelers. The FDA regulates Indocyanine Green manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indocyanine Green 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 Indocyanine Green manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Indocyanine Green Suppliers

A Indocyanine Green supplier is an individual or a company that provides Indocyanine Green active pharmaceutical ingredient (API) or Indocyanine Green finished formulations upon request. The Indocyanine Green suppliers may include Indocyanine Green API manufacturers, exporters, distributors and traders.

click here to find a list of Indocyanine Green suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Indocyanine Green USDMF

A Indocyanine Green DMF (Drug Master File) is a document detailing the whole manufacturing process of Indocyanine Green active pharmaceutical ingredient (API) in detail. Different forms of Indocyanine Green DMFs exist exist since differing nations have different regulations, such as Indocyanine Green USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Indocyanine Green DMF submitted to regulatory agencies in the US is known as a USDMF. Indocyanine Green USDMF includes data on Indocyanine Green's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indocyanine Green USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Indocyanine Green suppliers with USDMF on PharmaCompass.

Indocyanine Green KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Indocyanine Green Drug Master File in Korea (Indocyanine Green KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Indocyanine Green. The MFDS reviews the Indocyanine Green KDMF as part of the drug registration process and uses the information provided in the Indocyanine Green KDMF to evaluate the safety and efficacy of the drug.

After submitting a Indocyanine Green KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Indocyanine Green API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Indocyanine Green suppliers with KDMF on PharmaCompass.

Indocyanine Green NDC

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 Indocyanine Green as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Indocyanine Green API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Indocyanine Green 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Indocyanine Green and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Indocyanine Green NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Indocyanine Green suppliers with NDC on PharmaCompass.

Indocyanine Green GMP

Indocyanine Green 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 Indocyanine Green 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 Indocyanine Green GMP manufacturer or Indocyanine Green GMP API supplier for your needs.

Indocyanine Green CoA

A Indocyanine Green CoA (Certificate of Analysis) is a formal document that attests to Indocyanine Green's compliance with Indocyanine Green specifications and serves as a tool for batch-level quality control.

Indocyanine Green CoA mostly includes findings from lab analyses of a specific batch. For each Indocyanine Green 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.

Indocyanine Green may be tested according to a variety of international standards, such as European Pharmacopoeia (Indocyanine Green EP), Indocyanine Green JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Indocyanine Green USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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