Sofgen CDMO

New Molecular Entities

With more than 40+ years of experience, Sofgen Pharma 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.

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Hormonal Products

We develop and manufacture specialized hormonal pharmaceutical products under strictly controlled conditions, designed to meet the highest quality, safety, and regulatory standards.

Our facilities, processes, and teams are purpose-built to handle highly sensitive and potent hormonal compounds, ensuring consistent performance, product integrity, and full regulatory compliance throughout the product lifecycle.

Manufacturing of specialized hormonal dosage forms under dedicated and controlled environments.

Robust quality systems aligned with global regulatory requirements.

Advanced controls to ensure operator safety, cross-contamination prevention, and product integrity.

Scalable processes supporting clinical development through commercial production.

End-to-end development from concept through commercial supply.

Tech Transfers

"Seamless, flexible tech-transfer process with excellent time-to-market"

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

Whether you're looking for branded or generic products, Sofgen CDMO offers complete expertise in the development of Rx and OTC products.

OTC/Rx

At Sofgen pharma we are experts in the formulation, development and manufacture of prescription (Rx) drugs for different applications including NDA, aNDA and 505(b2).

With our state-of-the art facility and proprietary technologies we are able to transform initial ideas into 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.

Driving Innovation In Consumer Healthcare

As patients and consumers continue to seek novel formats that deliver a completely new experience, at Sofgen CDMO 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 CDMO helps partners throughout the entire development process of specialized nutraceuticals.