List of Repurposed/505(b)(2) Drugs Companies in New Jersey - 10

An early stage start-up with three products in Pre-IND phase and several complex generics in the pipeline.

Aucta Pharmaceuticals, Inc. (AUCTA, Latin-improved, enhanced) is a technology-based company focusing on the development and commercialization of Branded Specialty Products and Technology Platform-based Niche Generics. Aucta is a pharmaceutical company creating enhanced products from proven molecules using the 505(b)(2) regulatory pathway. Through innovation, Aucta is creating new therapeutics, including new dosage forms, new dosing regimens, and new indications. Aucta has a clear therapeutic focus in CNS disorders, Ophthalmic, and Inhalation Therapy. We are committed to being patient-centric by continuously bringing improved forms of proven molecules into the marketplace. Aucta has operation in both New Jersey, U.S. and Shanghai, China. Our mission: Enhanced products from proven molecules!

Citius Pharmaceuticals, Inc., a specialty pharmaceutical company, develops and commercializes critical care products. It primarily focuses on developing anti-infective, cancer care, prescription, and mesenchymal stem cell therapy products. The company is developing Mino-Lok, an antibiotic lock solution used to treat patients with catheter-related bloodstream infections by salvaging the infected catheter, which is in Phase III clinical trials; Mino-Wrap, a liquifying gel-based wrap for reduction of tissue expander infections following breast reconstructive surgeries; Halo-Lido, a corticosteroid-lidocaine topical formulation that is intended to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids; and NoveCite, a mesenchymal stem cell therapy for the treatment of acute respiratory disease syndrome. Citius Pharmaceuticals, Inc. was founded in 2007 and is headquartered in Cranford, New Jersey.

LipoSeuticals is a specialty pharmaceutical company that engages in the development, manufacturing and commercialization of parenteral drug products.

Mestastop Solutions is a biotechnology startup based in India, focused on addressing cancer metastasis. The company aims to develop innovative solutions to combat the spread of tumors, which significantly contributes to cancer-related deaths worldwide. Mestastop has gained global recognition for its research, presenting its work at major international conferences such as the American Association of Cancer Research Annual Conference and the European Association of Cancer Research. The company is involved in diagnostics and discovery related to cancer metastasis, with a focus on small molecule drugs to tackle distant metastasis. Mestastop's approach includes unraveling the biology of metastasis to create targeted treatments. The company has been vetted by the scientific outsourcing platform Science Exchange and is recognized as an authorized service provider, underscoring its credibility in the field.

Novelstar Pharmaceuticals Inc., founded in August, 2018, is a Company of Fosun Pharma focusing on the development of special pharmaceutical products of NDA and ANDA with advanced drug delivery systems. Our parent company, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. was founded in 1994 and is a leading health and medical industry group in China. Fosun Pharma has a mission to promote human health. Its business covers the whole pharmaceutical industry chain, including drug manufacturing and R & D, medical services, medical device and medical diagnostics, pharmaceutical distribution and retail. Fosun Pharma has a state-of-the-art innovative technology center and an international R & D team. It continuously focuses on innovative research and development in cardiovascular, central nervous system, blood system, metabolism and digestive system, anti-infective and anti-tumor therapeutic fields. Facing the future, Fosun Pharma will adhere to the brand philosophy of "continuing to innovate and enjoy health" and continue to adhere to the development strategy of "endogenous growth, outward expansion and integrated development", and strive to become the first-class enterprise in the global mainstream medical and health market. Learn more on the FosunPharma website: https://www.fosunpharma.com/en/

Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders.

Starton Therapeutics is a clinical-stage biotechnology company that is transforming standard-of-care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) are the most common blood cancers in the United States. There is no treatment to help people with CLL to stay in remission, and while advances in treatment have provided people with MM a multitude of treatment options, they struggle with long-term tolerance of high doses, which may be more effective but come with a multitude of side effects. Starton's team of some of the best in clinical development and hematology/oncology have come together to change the fate for people struggling with the impact of their diseases. If dose-related side effects can be reduced and people can tolerate maintenance therapy for decades to help stay in remission, these cancers – which were previously a death sentence – would become more akin to chronic diseases, with a long lifespan and healthy quality of life. Starton is one of the few life sciences companies funded exclusively by individual investors. We have a business model that is lower risk, faster to market and less capital intensive than biotech companies developing medicines from scratch.

We Specialize in Urology and Women’s Health Care.Pain, urgency, frequency. Every day, urologic disorders continue to affect the lives of people all around us. Vaneltix is focused on providing immediate relief for patients suffering from Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS), a disease of the lower urinary tract that predominantly affects women.

YARAL Pharma Inc. is the US subsidiary of IBSA, a global pharmaceutical company headquartered in Switzerland. By focusing on people and innovating the ways they're cared for, YARAL Pharma is proud to offer the same values and expertise of its parent company to the US market. Dedicated to ensuring access to affordable authorized generics (AGs) and complex generic medicines that enhance healthcare outcomes, YARAL Pharma offers its customers high-quality products across a range of therapeutic areas, continuity of supply, and a commitment to exceptional customer service.