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Also known as: Eptifibatide acetate, 148031-34-9, 188627-80-7, 2-[20-carbamoyl-12-[4-(diaminomethylideneamino)butyl]-3-(1h-indol-3-ylmethyl)-2,5,8,11,14,22-hexaoxo-17,18-dithia-1,4,7,10,13,21-hexazabicyclo[21.3.0]hexacosan-6-yl]acetic acid, Eptifibatide (inn), L-cysteinamide,n6-(aminoiminomethyl)-n2-(3-mercapto-1-oxopropyl)-l-lysylglycyl-l-a-aspartyl-l-tryptophyl-l-prolyl-, cyclic (16)-disulfide

Molecular Formula

C₃₅H₄₉N₁₁O₉S₂

Molecular Weight

832.0 g/mol

InChI Key

CZKPOZZJODAYPZ-UHFFFAOYSA-N

1 2D Structure

Eptifibatide

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[20-carbamoyl-12-[4-(diaminomethylideneamino)butyl]-3-(1H-indol-3-ylmethyl)-2,5,8,11,14,22-hexaoxo-17,18-dithia-1,4,7,10,13,21-hexazabicyclo[21.3.0]hexacosan-6-yl]acetic acid

2.1.2 InChI

InChI=1S/C35H49N11O9S2/c36-30(51)25-18-57-56-13-10-27(47)42-22(8-3-4-11-39-35(37)38)31(52)41-17-28(48)43-23(15-29(49)50)32(53)44-24(14-19-16-40-21-7-2-1-6-20(19)21)34(55)46-12-5-9-26(46)33(54)45-25/h1-2,6-7,16,22-26,40H,3-5,8-15,17-18H2,(H2,36,51)(H,41,52)(H,42,47)(H,43,48)(H,44,53)(H,45,54)(H,49,50)(H4,37,38,39)

2.1.3 InChI Key

CZKPOZZJODAYPZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CC2C(=O)NC(CSSCCC(=O)NC(C(=O)NCC(=O)NC(C(=O)NC(C(=O)N2C1)CC3=CNC4=CC=CC=C43)CC(=O)O)CCCCN=C(N)N)C(=O)N

2.2 Synonyms

2.2.1 Depositor-Supplied Synonyms

1. Eptifibatide Acetate

2. 148031-34-9

3. 188627-80-7

4. 2-[20-carbamoyl-12-[4-(diaminomethylideneamino)butyl]-3-(1h-indol-3-ylmethyl)-2,5,8,11,14,22-hexaoxo-17,18-dithia-1,4,7,10,13,21-hexazabicyclo[21.3.0]hexacosan-6-yl]acetic Acid

5. Eptifibatide (inn)

6. L-cysteinamide,n6-(aminoiminomethyl)-n2-(3-mercapto-1-oxopropyl)-l-lysylglycyl-l-a-aspartyl-l-tryptophyl-l-prolyl-, Cyclic (16)-disulfide

7. Eptifitide

8. Integrilin (tn)

9. Schembl1649793

10. Schembl8284422

11. Chembl4303580

12. Dtxsid60861477

13. Hms3743e11

14. Amy25372

15. Bcp02070

16. Db-044679

17. Ft-0602106

18. Ft-0652986

19. D06888

20. Sr-01000942234

21. Sr-01000942234-1

22. 148031-34-9;eptifibatide Acetate; Integrilin; Integrelin

23. {11-(4-carbamimidamidobutyl)-3-carbamoyl-20-[(1h-indol-3-yl)methyl]-1,9,12,15,18,21-hexaoxodocosahydro-7h-pyrrolo[2,1-g][1,2,5,8,11,14,17,20]dithiahexaazacyclotricosin-17-yl}acetic Acid

24. L-cysteinamide,n6-(aminoiminomethyl)-n2-(3-mercapto-1-oxopropyl)-l-lysylglycyl-l-a-aspartyl-l-tryptophyl-l-prolyl-, Cyclic (1?6)-disulfide

2.3 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₃₅H₄₉N₁₁O₉S₂
Molecular Weight	832.0 g/mol
XLogP3	-2.4
Hydrogen Bond Donor Count	10
Hydrogen Bond Acceptor Count	12
Rotatable Bond Count	10
Exact Mass	831.31561453 g/mol
Monoisotopic Mass	831.31561453 g/mol
Topological Polar Surface Area	377 Å²
Heavy Atom Count	57
Formal Charge	0
Complexity	1520
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	5
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Integrilin
PubMed Health	Eptifibatide (Injection)
Drug Classes	Platelet Aggregation Inhibitor
Drug Label	Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N6-(aminoim...
Active Ingredient	Eptifibatide
Dosage Form	Injectable
Route	Injection
Strength	2mg/ml; 75mg/100ml
Market Status	Prescription
Company	Schering

2 of 2
Drug Name	Integrilin
PubMed Health	Eptifibatide (Injection)
Drug Classes	Platelet Aggregation Inhibitor
Drug Label	Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N6-(aminoim...
Active Ingredient	Eptifibatide
Dosage Form	Injectable
Route	Injection
Strength	2mg/ml; 75mg/100ml
Market Status	Prescription
Company	Schering

4.2 Therapeutic Uses

Platelet Aggregation Inhibitors

National Library of Medicine's Medical Subject Headings. Eptifibatide. Online file (MeSH, 2016). Available from, as of January 20, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html

/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Eptifibatide is included in the database.

NIH/NLM; ClinicalTrials.Gov. Available from, as of March 17, 2016: https://clinicaltrials.gov/ct2/results?term=Eptifibatide&Search=Search

Integrilin is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).

NIH; DailyMed. Current Medication Information for Integrilin (Eptifibatide) Injection, Solution (Updated: January 2015). Available from, as of January 20, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5423624f-a2d8-4273-8c62-51839fccfd7e

Integrilin is indicated to decrease the rate of a combined endpoint of death, new myocardial infarction (MI), or need for urgent intervention in patients undergoing percutaneous coronary intervention (PCI), including those undergoing intracoronary stenting. /Included in US product label/

Eptifibatide has been administered concomitantly with a thrombolytic agent (e.g., alteplase, tenecteplase) in a limited number of patients to prevent coronary artery reocclusion after an acute myocardial infarction. /NOT included in US product label/

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1537

4.3 Drug Warning

The most frequent and severe adverse effect of eptifibatide therapy is bleeding. Bleeding complications, which usually are minor and develop at vascular access (e.g., femoral puncture) sites (e.g., in patients undergoing percutaneous coronary intervention (PCI)), have been reported in 35-75% of patients receiving various dosages of eptifibatide in clinical studies. Bleeding is an extension of the pharmacologic action of eptifibatide and was classified in clinical trials principally according to criteria of the Thrombolysis in Myocardial Infarction (TIMI) study groups. Minor bleeding generally was defined as spontaneous gross hematuria or spontaneous hematemesis; observed blood loss with a decrease in hemoglobin concentration of 3-5 g/dL or a reduction in hematocrit of at least 10%; or a decrease of 4-5 g/dL or 12-15% in hemoglobin or hematocrit, respectively, with no identifiable bleeding site. Major bleeding was defined as intracranial hemorrhage or overt bleeding associated with a hemoglobin or hematocrit decrease of at least 5 g/dL or at least 15%, respectively.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1538

Because eptifibatide increases the risk of bleeding, the drug is contraindicated in patients with a history of bleeding diathesis or active abnormal bleeding (e.g., elevated hemostatic indices, recent noncompressible vascular punctures GI or genitourinary bleeding) within the previous 30 days. A low hematocrit value (less than 30%) at baseline could represent recent undetected bleeding, and patients with such values may not be able to tolerate additional bleeding episodes; eptifibatide should not be used in these patients. Eptifibatide also is contraindicated in patients with severe uncontrolled hypertension (systolic blood pressure exceeding 200 mm Hg or diastolic blood pressure exceeding 110 mm Hg with antihypertensive therapy); recent (within 6 weeks) major surgery; history of stroke within 30 days or any history of hemorrhagic stroke; current or planned therapy with another GP IIb/IIIa-receptor inhibitor; and patients receiving renal dialysis. No data are available on the use of eptifibatide in patients with serum creatinine concentrations of 4 mg/dL or greater; the dosage should be reduced in patients with serum creatinine concentrations between 2-4 mg/dL.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1539

FDA Pregnancy Risk Category: B /NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility./

Safety and effectiveness of Integrilin in pediatric patients have not been studied.

For more Drug Warnings (Complete) data for Eptifibatide (15 total), please visit the HSDB record page.

5 Pharmacology and Biochemistry

5.1 Absorption, Distribution and Excretion

/MILK/ It is not known whether eptifibatide is distributed into milk in humans.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1541

Eptifibatide is approximately 25% bound to plasma proteins, principally (9-16%) to albumin.The volume of distribution of eptifibatide in patients with coronary artery disease is about 185-260 mL/kg and is somewhat higher (220-270 mL/kg) in healthy individuals.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1541

Eptifibatide, a synthetic peptide inhibitor of the platelet glycoprotein IIb/IIIa receptor, has been studied as an antithrombotic agent in a variety of acute ischemic coronary syndromes. The purpose of the present study was to characterize the disposition of (14)C-eptifibatide in man after a single intravenous (i.v.) bolus dose. (14)C-Eptifibatide (approximately 50 uCi) was administered to eight healthy men as a single 135-ug/kg IV bolus. Blood, breath carbon dioxide, urine, and fecal samples were collected for up to 72 hours postdose and analyzed for radioactivity by liquid scintillation spectrometry. Plasma and urine samples were also assayed by liquid chromatography with mass spectrometry for eptifibatide and deamidated eptifibatide (DE). Mean (+/- SD) peak plasma eptifibatide concentrations of 879 +/- 251 ng/mL were achieved at the first sampling time (5 minutes), and concentrations then generally declined biexponentially, with a mean distribution half-life of 5 +/- 2.5 minutes and a mean terminal elimination half-life of 1.13 +/- 0.17 hours. Plasma eptifibatide concentrations and radioactivity declined in parallel, with most of the radioactivity (82.4%) attributed to eptifibatide. A total of approximately 73% of administered radioactivity was recovered in the 72-hour period following (14)C-eptifibatide dosing. The primary route of elimination was urinary (98% of the total recovered radioactivity), whereas fecal (1.5%) and breath (0.8%) excretion was small. Eptifibatide is cleared by both renal and nonrenal mechanisms, with renal clearance accounting for approximately 40% of total body clearance. Within the first 24 hours, the drug is primarily excreted in the urine as unmodified eptifibatide (34%), DE (19%), and more polar metabolites (13%).

PMID:9589822 Alton KB et al; Clin Ther 20 (2): 307-23 (1998)

Plasma clearance of eptifibatide is proportional to body weight and estimated creatinine clearance and inversely proportional to age. Following a single IV dose of (14)C-radiolabeled eptifibatide (135 ug/kg) in healthy men, renal clearance averaged approximately 40-50% of total body clearance. Clearance is reduced by 50% in patients with moderate to severe renal impairment (estimated Clcr less than 50 mL/minute). Total body clearance in geriatric patients with coronary artery disease is lower than that in younger adults.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1541

For more Absorption, Distribution and Excretion (Complete) data for Eptifibatide (9 total), please visit the HSDB record page.

5.2 Metabolism/Metabolites

(14)C-eptifibatide was extensively metabolized to deamidated eptifibatide and to several polar metabolites by both rats and monkeys. The drug-derived radioactivity excreted into the bile by rats, and identified as deamidated eptifibatide, was reabsorbed from the intestinal tract and further metabolized to more polar metabolites. The plasma and urine metabolite profiles in rats and monkeys indicate that the metabolic disposition of eptifibatide is similar for the two species.

Health Canada; Product Monograph for Integrilin (Eptifibatide Injection), Drug Identification Number (DIN): 02240351 p.25 (Date of Preparation: February 16, 2011).

Eptifibatide is metabolized principally through deamidation to a metabolite that has approximately 41% of the platelet-aggregation inhibitory activity of the parent compound, and through formation of other more polar metabolites. Approximately 27% of a dose of eptifibatide is broken down in plasma into naturally occurring amino acids; no major non-amino acid metabolites have been detected in plasma in humans.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1541

5.3 Biological Half-Life

In Cynomolgus monkeys, plasma concentrations of (14)C-eptifibatide-derived radioactivity declined with a half life of about 12 hours following a single 2 mg/kg IV dose of (14)C-eptifibatide. Unchanged eptifibatide, which accounted for approximately 93% of total plasma (14)C at 5 min post-dose, was eliminated rapidly with a half life of 17 min.

Health Canada; Product Monograph for Integrilin (Eptifibatide Injection), Drug Identification Number (DIN): 02240351 p.24 (Date of Preparation: February 16, 2011). Available from, as of March 8, 2016: https://webprod5.hc-sc.gc.ca/dpd-bdpp/start-debuter.do?lang=eng

In rats, plasma concentrations of (14)C-eptifibatide-derived radioactivity declined rapidly with a terminal phase half life of about 5 hours following a single 2 mg/kg IV dose of the radiolabeled drug. Unchanged eptifibatide declined with an apparent half life of about 8 min. Following single 2 and 20 mg/kg IV doses, the plasma concentrations of eptifibatide were dose-proportional and the half life (11 to 12 min) was dose-independent, indicating linear kinetics within the 2 to 20 mg/kg dose range.

The half-life of eptifibatide in patients with coronary artery disease averages 2.5-2.8 hours. In healthy individuals, half-life of the drug reportedly averages 0.83-2.4 hours.

American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 1541

... The purpose of the present study was to characterize the disposition of (14)C-eptifibatide in man after a single intravenous (IV) bolus dose. (14)C-Eptifibatide (approximately 50 uCi) was administered to eight healthy men as a single 135-ug/kg IV bolus. ... Mean (+/- SD) peak plasma eptifibatide concentrations of 879 +/- 251 ng/mL were achieved at the first sampling time (5 minutes), and concentrations then generally declined biexponentially, with a mean distribution half-life of 5 +/- 2.5 minutes and a mean terminal elimination half-life of 1.13 +/- 0.17 hours. ...

PMID:9589822 Alton KB et al; Clin Ther 20 (2): 307-23 (1998)

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SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"TAPI TECHNOLOGY & API SERVICES","supplierCountry":"UNITED KINGDOM","foreign_port":"N\/A","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"3.64","actualQuantity":"3637","unit":"GMS","unitRateFc":"190","totalValueFC":"699803.2","currency":"USD","unitRateINR":"16017","date":"08-Dec-2023","totalValueINR":"58253829","totalValueInUsd":"699803.2","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"1004960","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 107, 1019 GM AMSTERDAM THE NETHERLANDS NL","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708626600,"product":"EPTIFIBATIDE - 770P87450 -LOT#874500124 (QTY 3226 GRMS)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"TAPI TECHNOLOGY & API SERVICES","supplierCountry":"ISRAEL","foreign_port":"TEL AVIV YAFO","customer":"VIATRIS","customerCountry":"INDIA","quantity":"3.23","actualQuantity":"3226","unit":"GMS","unitRateFc":"231.4","totalValueFC":"754959.9","currency":"USD","unitRateINR":"19417.8","date":"23-Feb-2024","totalValueINR":"62641874.42","totalValueInUsd":"754959.9","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"2274732","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV YAFO","supplierAddress":"Piet Hein Building, Piet Heinkade 107 1019 GM Amsterdam The Netherlands Netherlands","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714069800,"product":"EPTIFIBATIDE (101 G)","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"SINOPEP-AIISINO","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"JODAS EXPOIM PVT. 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LTD","customerCountry":"INDIA","quantity":"0.40","actualQuantity":"0.4","unit":"KGS","unitRateFc":"105000","totalValueFC":"42400.3","currency":"USD","unitRateINR":"8883000","date":"30-Sep-2024","totalValueINR":"3553200","totalValueInUsd":"42400.3","indian_port":"Hyderabad Air","hs_no":"29371900","bill_no":"5879599","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.28 LINPU ROAD ECONOMIC &TECHNOL OGICAL DEVELOPMENT ZONE SDNF China","customerAddress":"101, SITARAM MANSION,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735583400,"product":"EPTIFIBATIDE - 770P87450 - BATCH # 874500524 EPTIFIBATIDE - 770P87450 - BATCH # 874500524","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"TAPI NL B.V.","supplierCountry":"ISRAEL","foreign_port":"TEL AVIV YAFO","customer":"VIATRIS","customerCountry":"INDIA","quantity":"3.90","actualQuantity":"3898","unit":"GMS","unitRateFc":"242","totalValueFC":"954049.4","currency":"USD","unitRateINR":"20796.5","date":"31-Dec-2024","totalValueINR":"81064608.88","totalValueInUsd":"954049.4","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"7550080","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"TEL AVIV YAFO","supplierAddress":"Piet Heinkade 55 1019 GM Amsterdam SDNF SDNF Netherlands","customerAddress":"564\/A\/22, ROAD NO.92"}]

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DOSAGE - INJECTABLE;INJECTION - 2MG/ML **Fede...DOSAGE - INJECTABLE;INJECTION - 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20718

DOSAGE - INJECTABLE;INJECTION - 75MG/100ML **...DOSAGE - INJECTABLE;INJECTION - 75MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20718

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ABOUT THIS PAGE

Eptifibatide Manufacturers

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

Eptifibatide Suppliers

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

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

Eptifibatide USDMF

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

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

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

Eptifibatide 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 Eptifibatide as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Eptifibatide 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 Eptifibatide 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 Eptifibatide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eptifibatide NDC to their finished compounded human drug products, they may choose to do so.

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

Eptifibatide GMP

Eptifibatide 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 Eptifibatide 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 Eptifibatide GMP manufacturer or Eptifibatide GMP API supplier for your needs.

Eptifibatide CoA

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

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

Eptifibatide may be tested according to a variety of international standards, such as European Pharmacopoeia (Eptifibatide EP), Eptifibatide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eptifibatide 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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INJECTABLE;INJECTION - 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 75MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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INJECTABLE;INJECTION - 2MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 75MG/100ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons