List of Contract Manufacturing Companies in New Jersey - 25

3D Biotek, LLC is a high tech biomedical engineering company located in the state of New Jersey, USA. Using its Precision 3D Micro-fabrication Technology and Advanced Bio-manufacturing Technology, 3D Biotek is a leader and the industry's only dedicated driving force in the research and development of novel 3-dimensional cell culture devices for stem cell/tissue engineering, drug discovery and broad cell biology applications.

Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services, from product development through commercial manufacturing and packaging, with expertise focusing on oral dosage forms for the Pharmaceutical industry. Adare's specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. With a proven history in drug delivery, Adare has developed and manufactures more than 45 products sold by customers worldwide.

A single idea, which sprouts from a human mind, contains the potential to create marvels that can influence generations. It can redefine rules, it can transform the world. Back in the year 1973, a team of individuals came with such an idea – The idea called Alkem. It was highly potent and resilient, like a spark that could ignite a thousand more ideas. And it did! Looking back at our 4 decade, illustrious journey, that one small idea has Not only triggered us to become one of India’s largest generic and specialty pharmaceutical company but also, create a foothold in over 50 countries 32% of our revenue is generated via offshore sales. As well as we have consistently been ranked amongst the top ten pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D and Taxim-O, which feature amongst top 50 pharmaceutical brands in India. For over a decade, our dominance in anti-infective segment has remained unchallenged. We have 21 manufacturing facilities at multiple locations in India and the United States of America. Our upper-crest facilities are inspected and audited as per cGMP guidelines as laid down by leading regulatory authorities such as USFDA, MHRA - UK, SAHPRA-South Africa, TGA - Australia, ANVISA - Brazil, WHO - Geneva, TPD - Health Canada, PPB - Kenya, NDA - Uganda, MOH - Sudan, INVIMA - Colombia, TFDA - Tanzania, Zimbabwe, BfArM-Germany & Other Africa, Asian & CIS Countries. Another feather in our cap was added on December 23rd, 2015, when, Alkem completed it's Initial Public Offering (IPO) and was listed on the Bombay Stock Exchange Limited and the National Stock Exchange of India Limited. Although passion is the fuel that keeps ideas alive, innovation is the catalyst that gives it flight! With over 500 scientists working in 5 global R&D centers, we are empowering innovations that align with our philosophy of ‘Extended Lifecare Beyond Boundaries’.

Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the-counter brands (OTC) and biosimilar products for patients around the world. We are passionate about making people's lives better by making high quality medicines more accessible around the world. The company has commercial operations in 35 countries with 2,800 employees and operates four manufacturing and development hubs in the U.S., Romania, Korea and Taiwan. North America is Alvogen's single largest market and other key markets include: South Korea, Russia, Taiwan, Romania, Hungary, Ukraine, Japan and China.

API Pharmatech is focused on delivering Quality therapeutic products, satisfying Regulatory and Statutory necessities thereby, ensuring safety and purity to its products. We indulged in developing and manufacturing generic and innovative APIs and FDFs. Well capable of resources and expertise to pull out an API from development to commercial scale manufacturing, fulfilling all the required statutory regulations and inspections and involving in the development, manufacturing and marketing of the drug. API Pharmatech constantly updates its knowledge and identifies niche and complex APIs and FDFs which are technologically challenged.

Apprentice provides an all-in-one, cloud-native platform (Tempo Manufacturing Cloud) that is purpose-built for regulated industries, and covers a wide range of manufacturing use cases across multiple industry verticals. Within life sciences, Tempo accelerates the end-to-end drug product lifecycle by connecting together distributed teams and sites, helping them execute better on the shop floor, and optimizing their operations through enterprise-wide visibility. Apprentice is trusted by global manufacturing leaders across various regulated industries. Tempo users belong to organizations responsible for contract manufacturing, cell & gene therapy, CRISPR technology, biopharma, biotechnology and adjacent industries.

Arbela Labs is a New Jersey-based company focused on increasing the scale and reducing the costs of biomanufacturing using its methanol-fed Pichia platform.

Based in North Brunswick, New Jersey, Ascendia Pharmaceuticals is a specialty contract development and manufacturing (CDMO) company dedicated to delivering sophisticated formulations of existing drug products, and enabling formulations for preclinical- and clinical-stage drug candidates. Ascendia Pharmaceuticals is your ideal partner for: · Early stage IND-enabling formulations for toxicology and pharmacokinetic (PK) studies · Rapid development through Phase I CTM materials for oral and parenteral dosage forms · Fast discovery formulation support · Formulation development and CTM manufacturing for specialty pharmaceuticals Ascendia Pharmaceuticals also provides special development programs: · Formulations for poorly soluble and low bioavailability drugs · First-in-man injectable formulations · Nano-emulsion and nano-particle formulations · Peptide formulations · Sustained release by parenteral or oral routes · Development of 505(b)(2) products · Development of complex generics · High potency and DEA controlled drug substances · Ocular formulation development · Animal health formulations

AustarPharma is a pharmaceutical company that specializes in drug delivery technologies.

BioCentriq is a premier contract development and manufacturing organization (CDMO) dedicated to advancing cell therapy. Since 2019, the company has specialized in GMP autologous and allogeneic cell therapies, offering end-to-end clinical-to-commercial capable services tailored to clients’ unique needs. Operating from two state-of-the-art U.S.-based facilities, BioCentriq provides a comprehensive range of services, including technology transfer and new technology evaluations, process and analytical development, cGMP manufacturing, quality control lot release, and stability studies. The company’s expertise spans diverse cell therapy modalities, such as T-cell (CAR-T, TCR), NK-cell, iPSC, and MSC-based products. With its proprietary LEAP™ manufacturing platform, BioCentriq accelerates service timelines while offering standardized and customizable solutions, including traditional fee-for-service, hybrid and person-in-plant operations, dedicated cleanroom capacity, and flexible service and contract arrangements. In addition to its technical capabilities, BioCentriq operates the Cell and Gene Therapy Experiential Learning Center, a training facility which provides hands-on and virtual instruction under the guidance of industry-experienced instructors and subject matter experts. The program has trained hundreds of participants, hosted major pharmaceutical companies, and integrates next-generation technologies and concepts into its curriculum including: Industry 4.0 and Lean principles, predictive analytics, augmented reality, and electronic batch record systems. Backed by GC Corporation, a South Korea-based leader in the healthcare, pharmaceutical and biotechnology industry, BioCentriq combines global expertise with a flexible working relationship, set to empower clients to develop and deliver cutting-edge, personalized therapies with unmatched precision and efficiency.

API Services

Established in 2010, Crystal Pharmatech is a specialized CRO/CDMO, excelling in crystal form and formulation services. Our exceptional track record includes supporting 1,000 clients and collaborating on over 2,000 compounds, showcasing our expertise in solid-state research, crystallization, pre-formulation, formulation development, and manufacturing. With a global presence encompassing three strategically located R&D centers in New Jersey (USA), Toronto (Canada), and Suzhou (China), we are powered by a skilled team of around 250 professionals. As a leader in both conventional and enabling formulation technologies, including amorphous solid dispersion, we take pride in our cGMP facilities, strictly adhering to the rigorous standards set by the FDA, EMA, and NMPA. Our integrated service encompasses the entire new drug development journey, from developability assessment and solid form screening to pre-formulation, formulation development, and CTM and commercial manufacturing. Introducing our pioneering Mol2Med program, designed to expedite small molecule lead compounds or preclinical candidates into Phase I and beyond, with unparalleled efficiency and precision. This 3-step First-Time-Right approach begins at the lead optimization/PCC stage: Step 1: Developability Assessment to guide API form selection and formulation design. Step 2: Solid form screening/selection and Preformulation. Step 3: Formulation development and CTM manufacturing, including packaging, labeling, and shipping to the clinical site. This innovative approach guarantees a robust API form and a scalable manufacturing process, culminating in a First-Time-Right formulation for Phase I. Streamlining the transition to future clinical studies upon Phase I success, our First-Time-Right approach sets the foundation for optimized drug development and success beyond.

DermaRite manufactures cost-effective skin care, wound care, and nutritional supplements for healthcare facilities, including hospitals, nursing homes, hospice, and home care. Founded in 1995, DermaRite's state of the art manufacturing and warehousing facility is in North Bergen, New Jersey. With a distribution and sales network throughout the United States, facilities can be assured of fast, reliable service and personalized attention. DermaRite customers also receive access to a wide range of clinical and educational tools, making us one of the best values in the industry. DermaRite is an FDA and OSHA approved manufacturer.

Emcure Pharmaceuticals Ltd. (EPL) is an Indian pharmaceutical company headquartered in Pune engaged in developing, manufacturing and globally marketing a broad range of pharmaceutical products across several major therapeutic areas. Established in 1981, EPL is ranked as the 11th largest company in Indian Pharmaceutical Market as per AWACS MAT Feb'24 data.

Evergreen Theragnostics was established in 2019 to be a leading US-based radiopharmaceutical Contract Development and Manufacturing Organization (CDMO). Our team’s expertise and track record in theragnostic radiopharmaceutical commercialization, manufacturing process development, and regulatory affairs management, make us your ideal partner for all of your radiopharmaceutical development, manufacturing, and commercialization needs.

Are you ready for a better CDMO experience? You've found it. At Experic, we specialize in the development, clinical and commercial manufacturing, and global logistics services that help our biopharmaceutical customers succeed. Our 45,500-square-foot, state-of-the-art facility located in New Jersey is designed for advanced powder filling and low-dose dry powder inhalation products but is built to accommodate a variety of drug delivery formats, including liquids and highly potent products. From initial product concepts to manufacturing, packaging, and patients, our team of seasoned experts and project managers seamlessly blend cutting-edge capabilities and customized solutions tailored to your needs. Our end-to-end services include: • Formulation and process development • Spray drying expertise • Powder blending and filling • Risk-mitigation mindset • Clinical and commercial manufacturing • Encapsulation/over-encapsulation • Primary and secondary packaging • Robust quality culture • Full suite of analytical services • Global clinical trial logistics from our US & EU depots • Expansion space available for custom suites • Experic experts on-call to provide you with peace of mind Experience a new approach to product lifecycle support and partner with us today!

Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

Kamat Phamatech LLC is a privately held technology-based pharmaceutical company located in Central New Jersey. We specialize in the development, manufacturing, and approval of novel parenteral and enteral products and processes, particularly in the areas of new chemical and biological entities for treatments of various indications.

Leading Pharma, LLC is a privately owned generic pharmaceutical company that purchases, licenses, develops, manufactures and distributes high-quality, safe and effective products to drugstore chains, distributors, wholesalers, mass merchandisers, government agencies and managed care accounts in the U.S. Our products are available in various dosage forms across many therapeutic areas under the Leading label. Product and Customer Related Inquiries – MEDICAL INFORMATION · Report Adverse Events / Side Effects · Report Product Complaints · Submit Medical Inquiries · Report Product Overdose and Poisoning Please contact us in the given details. By Phone: (844)-740-7500 By Fax: (973)-276-9656 By Email: micc_leadingpharma@mitoconbiopharma.com

Porton Advanced is a Cell and Gene Therapy (CGT) CDMO/CRO. We provide end-to-end research grade, process development (PD), analytical development (AD), GMP manufacturing, and testing services of AAV, Lentivirus, mRNA, and plasmid to meet clients’ therapeutic product needs at pre-clinical, clinical, and commercial stages. Our dedicated process and analytical development teams have established robust platform-based USP/DSP and GMP manufacturing capability and capacity, as well as proprietary technologies to further empower our clients’ successes. Our services include gene and cell engineering discovery research and technology licensing, process development and analytical development, testing, drug substances (DS) and drug products (DP), and cGMP manufacturing across plasmids, cell therapy, gene therapy, virotherapy, and mRNA-based therapeutic platforms.

As a premier, independently owned CDMO with over 65 years of sterile injectable manufacturing experience, Simtra BioPharma Solutions offers world-class cGMP sterile fill/finish, technical expertise, quality service, and a uniquely collaborative approach. Pharmaceutical and biotech companies partner with us when they face formulation challenges, clinical supply hurdles, surges in demand due to market fluctuations, or risk mitigation concerns. Our teams are driven to offer our clients tailored and versatile solutions to help them bring their products to market so they can get to the patients who need them. (Simtra is a tradename of Baxter Oncology GmbH and Baxter Pharmaceutical LLC)

Stira Pharmaceuticals is a Sterile Injectable CDMO with deep pharmaceutical product development and manufacturing experience in small molecules and peptides. At Stira Pharmaceuticals, a team of highly skilled and experienced scientists are developing challenging products using in-house technology platforms, technical know-how and in-depth prior experience. We offer services: Analytical R &D Preformation In Vitro Permeability Testing (IVPT) In Vitro Release Testing (IVRT) Extractables & Leachable Testing (E & L) Formulation Development Stability Testing Microbiology Regulatory Support

Sunrise Pharma is a premier provider of safe and affordable generic medicines. Sunrise was founded and is based in the United States. Our products appear in various dosage forms across multiple therapeutic areas. We market products to all pharmaceutical channels including local and national retailers, wholesalers, distributors, health systems, and government. We understand the role of medicine in our society and we are wholly committed to supplying top notch quality products to the US pharmaceutical market. Our aim is to provide a diverse portfolio of safe and affordable generic medications to millions of patients to lead a happier and healthier life.

Teligent is a pharmaceutical company that develops, manufactures and markets topical medicines and sterile injectable products.