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We are building a vibrant, sustainable company with the goal of delivering transformational medicines.
At Manifest, we constantly strive to bring the most advanced medicines within the reach of millions around the world. The efforts at our Biologics division, working on high quality global biosimilars for the last fifteen years, are a testament to that commitment. Diseases like cancer or autoimmune disorders often require the long term use of Biologics – large molecule protein therapies – for an effective treatment that may have fewer side effects. Effective as they are, biologics are very expensive and can place a significant cost burden on both, the patient as well as the payor.
Fortunately, our decades-long experience in the generics business, coupled with our world-class capabilities and best-in-class team allow us to create high quality, equally effective, but significantly more affordable generic biosimilars.Our product development capabilities and our global reach have quickly made us a leader in this relatively small, but fast-growing biosimilars segment. Manifest’s Laboratories leads the industry with four biosimilar products marketed in several countries, and with an extensive development pipeline.
As people continue to take greater responsibility for their own health and wellness issues, their needs change. Patients today are looking for more than just safe, effective medicines. They require information, coaching, and customized support to help them adhere to complex treatment protocols.
Our Proprietary Products division aims to fulfill these unmet patient needs. In some cases, this involves developing a new dosage of a current drug. In other cases, it may involve developing new combinations of synergistic medications. In doing so, we focus on improving the overall efficacy of the medicines.
While efficacy and safety are important, they are not the only considerations for successful adherence to a treatment protocol. This is why our Proprietary Products division focuses on initiatives to improve patient experience with our products. Better experience results in better compliance, which means better health and outcomes for patients.
Manifest combines our regulatory expertise and extensive training program with our proven staffing model to provide a flexible professional workforce. Our onsite staff placement is designed to help our clients retain quality, onsite regulatory staff without committing to additional full time employees.
Benefits of choosing Manifest's Staffing program:
• Network of over 150 regulatory professionals
• Extensive training program
• Both onsite and offsite staff depending on your needs
• Unique management program that supports the client and employee
• Low turnover due to our professional program and benefits
• 20+ years of experience
Custom Pharma Services has two decades of extensive experience in drug development, cGMP manufacturing for clinical and commercial supplies. Our services are based on our strong technology platforms and include:
• Complex and multi-step organic synthesis
• Asymmetric synthesis
• Classical resolution
• Organometallic/Metal hydride reactions
• Heterocyclic chemistry
• Halogenations
• Amino sugar chemistry
• Nucleoside synthesis
• High pressure hydrogenation
Our projects affirm our expertise.
In addition to this, Manifest offers indepth analysis on publicly traded pharma companies globally. It provides indepth research on their business model, potential for growth and sustainability of their research pipeline.
At Manifest we adopt ‘start with the end’ approach and consider formulation as the target irrespective of the stage at which we service: intermediates, API or formulation. Save time, cost and intellectual resources with our well-integrated product development program. Your API properties would govern the ease of formulation development. Optimise particle size, powder flow properties, solid state characteristics of API at CPS with our integrated API formulation services.
Manifest began producing Active Pharmaceutical Ingredients (APIs) in 1988 as a vital part of complex formulations and products to facilitate complete vertical integration. Today, the list of APIs exceeds 250 which is used for captive purposes as well as marketed to customers in over 60 countries across the world. We are trusted partners for many leading global generic and innovator companies.
In-house analytical capabilities for analytical method development and validation, solid state analysis and chemical analysis with hyphenated techniques in XRD, DSC, Ramsan spectroscopy, SEM, SAXS, LC-MS etc.
Our formulation services include:
• Preclinical formulations
• First-in-human formulations
• Clinical phase 2 and 3 formulationss
• Commercial manufacturing
• Life cycle managements
Our product list includes generics and complex APIs that require isolated manufacturing areas, like anti-cancers, peptides, steroids, sex hormones and controlled substances, including poppy-derived opiate raw materials that are primarily used in the manufacture of analgesics, sold as both Narcotic Raw Materials (NRM) and API's. We offer Bulk Actives, Intermediates and services for Custom Synthesis providing an integrated solution for the diverse requirements of generic and innovator companies.
