Eptifibatide powder

Xi'an Faithful BioTech Co., Ltd: Your Trusted Eptifibatide powder Manufacturer & Supplier

Eptifibatide powder is an artificially synthesized cyclic peptide containing one mercaptopropionic acid and six amino acid residues. It is a specific and targeted platelet glycoprotein GPIIb/IIIa receptor antagonist that selectively and reversibly inhibits the ultimate common pathway of platelet aggregation (plasma coagulation due to the binding of coagulation factor I to GP IIb/IIIa), and can reverse ischemic state caused by thrombosis. In clinical practice, the Eptifibatide API powder provided by Xi'an Faithful BioTech Co., Ltd. is mainly used to treat unstable angina and acute myocardial infarction. It is also listed as the most effective GP IIb/IIIa receptor antagonist in the current market, along with Tirofiban, and can be safely used in ACS patients undergoing PCI.

Eptifibatide powder Introduction

Eptifibatide powder has a modified amino acid chain of lysine-glycine-aspartic acid, which can bind to gp ⅱ b/ⅲ a receptor and block gp ⅱ b/ⅲ a receptor, so that coagulation factor ⅰ can not bind to platelet gp ⅱ b/ⅲ a receptor and play an anti-platelet aggregation role. The Eptifibatide acetate salt provided by Xi'an Faithful BioTech Co., Ltd. will lead to the combination of one coagulation factor I with two IIb/la receptors, while a platelet has multiple IIb/IIIa receptors, which can be combined with multiple coagulation factors I. The combination of coagulation factor I with IIb/IIIa receptors will lead to "bridging" of platelets and platelet aggregation. However, one Intrifiban molecule can only bind to one IIb/IIIa receptor, so the combination of INTEGRELIN and IIb/IIla receptor "blocks" IIb/IIIa receptor to play an anti-platelet aggregation role. In addition, the binding of Eptifibatide to GPⅡb/Ⅲa receptor is not only competitive, but also directional and specific, especially the rapid reversibility of our products, and does not increase the risk of bleeding. Let the long-term or repeated treatment of Eptifibatide acetate salt become a feasible scheme in the medical field.

Specifications

Why Choose Us? 

In the critical areas of acute coronary syndrome (ACS) and percutaneous coronary intervention (PCI), Eptifibatide, a highly effective glycoprotein IIb/IIIa inhibitor, is a vital tool for saving lives and reducing the incidence of myocardial infarction. The quality of its API directly impacts the safety and efficacy of the final drug product and ultimately patient outcomes.

Choosing our Eptifibatide API powder means choosing a strategic partner that meets top international standards for quality, compliance, reliability, and technical collaboration. This is more than just a supply chain choice; it's a responsibility to patients' lives.

I. Superior Quality Beyond Pharmacopoeia Standards: The Cornerstone of Efficacy and Safety

We understand that the structural complexity of peptide APIs, especially cyclic heptapeptides like Eptifibatide containing a unique sequence (including the RGD motif), places extreme demands on the production process.

• Ultra-high purity and strict impurity control: We utilize advanced solid-phase peptide synthesis (SPPS) and purification technologies, combined with multidimensional chromatographic purification systems (such as preparative HPLC), to ensure a product's primary purity is routinely above 99.5%. We also rigorously control known and unknown impurities and residual solvents through qualitative and quantitative controls, exceeding the standards of various pharmacopoeias, ensuring the safety window of the drug from the source.

• Confirmed structure and consistency: We use liquid chromatography-mass spectrometry (LC-MS) and nuclear magnetic resonance (NMR) to verify the amino acid sequence, correct disulfide bond pairing, and spatial structure of each batch of product, ensuring high consistency in biological activity with the reference product. Excellent batch-to-batch consistency is key to ensuring reproducible drug efficacy.

II. Strict compliance with international cGMP and comprehensive regulatory support
As a drug substance for injectables, a flawless production system is essential.

• Full cGMP Compliance: Our production facilities strictly adhere to international Good Manufacturing Practices (cGMPs), including ICH Q7. We have established a comprehensive, traceable quality management system, encompassing starting materials, production environment, process controls, and final release, ensuring we are audit-ready for global regulatory agencies such as the FDA, EMA, and NMPA.

• Complete Registration Document Support (DMF/CEP): We have prepared and submitted the Drug Master File (DMF) or, upon request, can provide all the technical support required for the European Pharmacopoeia Certificate of Suitability (CEP). This significantly simplifies the global registration process for your drug product, shortening time to market and reducing compliance costs.

III. Stable and Reliable Scaled Supply Chain: A stable supply of drugs is crucial to patient survival and requires no interruption.

• Strong Production Capacity: We have our own, large-scale API production line, capable of producing from kilogram-scale to commercial-scale batches, meeting your needs at every stage from clinical trials to commercial launch.

• Resilient Supply Chain: We utilize multiple suppliers for key starting materials and reagents, establishing a robust supply chain system to ensure long-term, continuous, and stable supply, eliminating the risk of supply disruptions in your drug production.

IV. The Value of Technology-Driven Strategic Partnerships

We are committed to transcending the traditional supplier role and becoming your trusted technology partner.

• In-depth Technical Collaboration: Our experienced technical team can provide in-depth technical support on Eptifibatide's physicochemical properties, optimal formulation processes (such as lyophilization curve recommendations), and stability studies, helping us overcome formulation development challenges.

• Customized Solutions: We can provide flexible commercialization solutions tailored to your specific needs, including customized sizes (such as large-scale customization) and specialized packaging (such as sterile primary packaging).

We sincerely invite you to contact us (email address:sales8@faithfulbio.com) to start a conversation about quality and trust. Please feel free to request detailed product specifications and confidentiality agreements (CDAs) for more in-depth technical information.

Mechanism action

Eptifibatide is a cyclic heptapeptide that is a glycoprotein IIb/IIIa receptor inhibitor with antiplatelet activity. Therefore, the Eptifibatide acetate salt we provide is mainly used for patients with acute coronary syndrome (unstable angina/non ST segment elevation myocardial infarction), including those receiving drug therapy and those undergoing percutaneous coronary intervention (PCI), ultimately achieving the combined endpoint of reducing the incidence of death or new myocardial infarction or requiring emergency intervention treatment. It should be noted that patients undergoing percutaneous coronary intervention (PCI) should also include those undergoing coronary stent implantation.

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Contact Us 

Ready to elevate your peptide products with our premium  Eptifibatide powder ? Contact our expert team today to discuss your needs and discover how Xi'an Faithful BioTech can support your business growth.

Email: sales8@faithfulbio.com

Experience the difference of working with a trusted product supplier. Let's build a successful partnership today!