Pharmacy Market
businesswire | August 31, 2023
Nexus Pharmaceuticals LLC announced it has received U.S. Food and Drug Administration (FDA) approval for 0.9% Sodium Chloride Injection, USP in 10mL and 20mL Single-Dose Vials.
“This product is part of an expanding portfolio of products that address critical healthcare challenges,” said Omair Ahmed, Chief Operating Officer. “Sodium Chloride Injection is used to treat patients every day in every hospital in the United States. We are grateful to be able to bolster the supply of this critical-need product.”
Nexus Pharmaceuticals’ 0.9% Sodium Chloride Injection, USP is expected to launch in October and will be available in cartons of 25 vials.
About 0.9% Sodium Chloride Injection, USP
Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
About Nexus Pharmaceuticals LLC
Nexus Pharmaceuticals LLC, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.
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Pharmacy Market
Businesswire | July 26, 2023
Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Sterile Water for Injection, USP in 10mL and 20mL Single-Dose Vials.
According to the FDA and the FD&C Act, the product is considered bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sterile Water for Injection USP, of Hospira, Inc. Furthermore, the FDA has granted CGT (competitive generic therapy) designation for the 20mL presentation of sterile water for injection.
“We are proud to be a force for change in the pharmaceutical industry, and we are grateful to the FDA for recognizing the importance of this critical-need product,” said Aman Ahmed, Director of Government Relations and International Sales at Nexus. “The approval of this product is an important step in continuing our efforts to alleviate drug shortages and bring pharmaceutical manufacturing back to the U.S.”
Nexus Pharmaceuticals’ Sterile Water for Injection will be available in cartons of 25 vials.
About Sterile Water for Injection, USP
Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
About Nexus Pharmaceuticals LLC
Nexus Pharmaceuticals LLC., a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.
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Pharmacy Market
PRNewswire | August 17, 2023
Frontage Laboratories, Inc. and its wholly-owned subsidiary, Frontage Canada, Inc., completed the acquisition of Nucro-Technics Inc. and its affiliate Nucro-Technics Holdings, Inc.
Nucro-Technics is a pharmaceutical contract research organization that conducts analytical chemistry, microbiology, toxicology, bioanalytical, and stability sample storage and testing services. In addition, it provides consulting services, especially in quality control and assurance as well as in Natural Health Product Regulations.
Nucro-Technics, located in the Toronto, Canada metropolitan area, operates in a state-of-the-art 60,000 square foot facility and employs personnel having expertise in testing both large and small molecules designed to treat various medical conditions. For over 50 years, Nucro-Technics has been conducting studies for various clients including major pharmaceutical, biotech, and medical device companies, as well as smaller organizations including industry trade groups and academia. Nucro-Technics has successfully developed and validated numerous methods, as well as participated in providing comprehensive IND packages to clients for regulatory submissions. Nucro-Technics, an ISO 9001:2015 certified organization, conducts studies that are in compliance with GLP and GMP regulations.
"Today marks a momentous and an exciting occasion. It is a day to celebrate two great companies coming together. It is with great pleasure that I welcome the extraordinary Nucro-Technics team to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "Nucro-Technics has been recognized as a leader in the Canadian CRO market for over 50 years, and its unparalleled client services is a perfect match for the culture of Frontage Laboratories. This acquisition not only significantly strengthens our presence in Canada, but also will enable the combined organization to offer a more expansive suite of services to clients across the globe. We are looking forward to partnering with the Nucro team to deliver the world-class expertise that clients have come to expect from us."
According to Dr. Song Li, Founder and Chairman of Frontage: "Nucro has developed a remarkable platform with a truly impressive team of experts. The closing of this transaction marks the next step in our ongoing effort to build Frontage into one of the major players in the global CRO market. In doing so, we will continue our focus on delivering the highest levels of quality, technology and expertise to our clients."
"I'm delighted to announce that we will be partnering with Frontage Labs for the next phase of Nucro Technics' growth journey. Since founding the business in 1970, we've worked hard to become the North American boutique in pre-clinical and drug product release testing services. Partnering with Frontage Labs marks an exciting chapter in the evolution of our efforts to support and accelerate pharmaceutical research and development," said John Fanaras of Nucro Technics.
Frontage was advised by Borden Ladner Gervais LLP (BLG) while Nucro-Technics was advised by Dentons and PricewaterhouseCoopers Corporate Finance Inc.
About Frontage
Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.
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