Sofgen Pharmaceuticals - Capabilities

With more than 20+ years of experience, Sofgen is a one-stop shop for bringing innovative drugs to life.

We offer pre-clinical and clinical development services for New Molecular Entities (NMEs). We are focused on helping companies right from the start, helping evaluate the safety and efficacy of entirely new drug candidates, employing a science-driven approach at every step, integrating powerful digital tools, supply assurance, regulatory support, and secure trial execution.

Confidently navigating the complexities of high-potency development and manufacturing.

Our extensive experience ensures expert handling of high potent compounds. Within our US a facility lies a dedicated 1,000 sq. ft. Highly Potent Compound Suite, readily available for your projects. This state-of-the-art suite houses a comprehensive array of specialized equipment, including a roller compactor, Fitzpatrick mill, bin blender, tablet press, and high-potency airlocks (locker room and material), ensuring maximum safety. Furthermore, the suite leverages the combined knowledge and capabilities of Sofgen Pharmaceuticals' global product development and manufacturing teams.

Seamless, felxible tech-transfer processes with excellent time-to-market

With our deep understanding in advanced delivery formats, Sofgen Pharmaceuticals offers solid processes, standardized operating procedures and top-of-the-line equipment essential for a successful tech-transfer.

Weather your looking for branded, generics or even private label, Sofgen offers complete expertise in the development of Rx and OTC products

Sofgen Pharmaceuticals: Your partner in innovation for Rx and OTC

At Sofgen we are experts in the formulation, development and manufacturing of prescription (Rx) drugs for different application including NDA, aNDA and 505(b2) With our state-of-the art facility and proprietary technologies we are able to transform initial ideas and transform them to safe, Top-of-the-line drugs. Our services include API selection, formulation, clinical site, submission batch manufacture, FDA filing, validation as well as Commercial Manufacturing.

Weather your looking for branded, generics or even private label, Sofgen offers complete expertise in the development of Rx and OTC products.

Driving Innovation in consumer healthcare

As patients and consumers continue to seek for novel formats that deliver a completely new experience, at Sofgen we understand what consumers prefer in terms of oral dosage forms and try to satisfy those needs through innovative options in OTC products. From Softgels, to chewable softgel technologies our innovative technologies become the perfect platform for the generation of brand value to consumer health brands.

Specialized Nutraceuticals

As leaders in the development and manufacturing of specialized nutraceuticals, we offer innovative, inclusive, enjoyable and convenient forms to meet the diversity of needs consumers crave. With a diverse library of ready-to-market products in diverse categories, or the flexibility to develop unique customized formulations, Sofgen helps partners throughout the entire development process of specialized Nutraceuticals.

Private Label

At Sofgen Pharmaceuticals, we specialize in delivering high-quality private label manufacturing services tailored to meet the needs of our clients. With state-of-the-art facilities, cutting-edge technology, and a dedicated team of experts, we offer comprehensive solutions from product development to final production. Our streamlined processes and efficient operations ensure a rapid time-to-market, allowing you to stay competitive in a dynamic industry. Our commitment to excellence guarantees that every product meets the highest standards of quality and regulatory compliance. Partner with us to bring your vision to life with customized, reliable, and market-ready pharmaceutical products.

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Schedule a meeting with one of our experts and visit our US site.

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Comprehensive CMO/CDMO Capabilities