List of APIs/Active Pharmaceutical Ingredients Companies in California - 13

AnaSpec, a subsidiary of Kaneka Eurogentec, is a globally recognized biotechnology company that manufactures and sells custom and catalog Peptides, Fluorogenic and FRET Assay Kits, Fluorescent Dyes, Amino Acids and more, for research use, drug discovery and diagnostic use. We also manufacture custom Peptide based starting materials for GMP applications. As a trusted and long-standing provider to the biopharmaceutical and diagnostic industries, academia, and governmental institutions, we aim to empower the scientific community in their endeavors to elucidate diseases and enhance health and well-being, through our quality proteomic products and services. Our team of experts strive for excellence with honesty and transparency on behalf of our customers. AnaSpec established in 1993 is certified to ISO 9001:2015.

Antheia is unlocking the medicinal power of nature. Its synthetic biology platform surpasses the limits of conventional drug discovery and manufacturing through a novel approach to whole cell engineering reconstructing complex molecules in yeast to bring to market next generation plant inspired medicines. Antheia’s team of scientists and technologists is headquartered in Menlo Park, California. For more information, visit www.antheia.bio.

CONTRACT PHARMA is the multi media information outlet dedicated to bio/pharma outsourcing. From drug development to manufacturing, we cover the latest developments, views and opinions from industry leaders in print and online. CONTRACT PHARMA offers advertising opportunities in our print magazine, Contract Pharma Direct weekly e newsletter and on contractpharma.com. We are the only worldwide print publication focused on Bio/Pharma contract services, delivering a total qualified circulation of 20,013. (VAC audit statement) On Sept. 26-27, 2024 CONTRACT PHARMA will host its 23rd Annual Contracting & Outsourcing Conference & Tabletop Exhibition. This event brings together speakers from the FDA, industry leaders, and expert analysts to discuss issues critical to success for Pharma & Biopharma outsourcing. The one-day Tabletop Exhibition of 160 top contract service providers provides great exposure to outsourcing decision makers. CONTRACT PHARMA's Corporate Capabilities and Contract Services Directory is the largest single source for company profiles and contract services. This standalone print issue showcases the services of Bio/Pharma contract service providers. The Contract Services Directory is also available online at www.contractpharma.com/csd. It's an indispensable guide for contract services in print and online. Every week, thousands of Bio/Pharma outsourcing professionals go to www.contractpharma.com to read current features, find archive stories, and get breaking news and online exclusives. We also e-mail CONTRACT PHARMA DIRECT, our weekly e-newsletter, to more than 20,000 people. CPDirect is filled with the latest news, our most recent articles, and links to our popular annual features and upcoming meetings. Free subscriptions are available on our website. Contact us for more information on how your company can get involved with Contract Pharma.

Debut is pioneering the beauty industry's shift from traditionally sourced ingredients derived from petroleum and cultivation to high-performing and inherently sustainable biotech ingredients. As a fully vertically-integrated global company, Debut creates superior, scientifically-engineered, bio-based and clinically-proven products and brands at scale to benefit people and planet. Our mission is to create a new beauty standard based on potency, purity, and performance.

Polaris Pharmaceuticals, is a biopharmaceutical development and manufacturing organization (CDMO) specializing in biologics derived from microbial systems. We have manufactured clinical material for trials in the United States, Europe, China, Taiwan, Australia, and Korea. Polaris Pharma offers a comprehensive range of process and analytical development and high-quality cGMP pre-clinical and clinical manufacturing services. We offer services for the following: • Process Development • Master and Working Cell Bank Propagation • Pre-Clinical/Clinical Manufacturing • QC Method Development • In Process Testing • Release Testing • Stability Storage and Testing • Availability to provide high purity WFI and PW • Custom Buffer and Media Manufacturing • Contract Filling, Labeling, Inspection • Microbial Based Fermentation Products

Emery Pharma (EP) (emerypharma.com) is a FDA registered/inspected, DEA licensed, and cGMP/GLP compliant full service contract research laboratory specializing in microbiology & cell-biology testing, medicinal chemistry, analytical chemistry, and bio-analytical services. EP is located in Alameda, CA, at the heart of San Francisco Bay area. We have been supporting clients both locally and globally. We have deep expertise in drug development and support clients from early preclinical all the way to Phase 3 clinical program. Our Bioanalytical Chemistry team utilizes the state of the art LCMS-MS instrument to unravel the targeted compounds in blood, plasma, skin, etc- We provide assistance with R&D method development, validation, method transfer and analytical services. Medicinal Chemistry: Our team has expertise in diverse therapeutic areas covers all aspects of medicinal chemistry, from strategic planning to hit evaluation and validation to lead optimization and pre-clinical development. Analytical Separation Chemistry: Utilizing NMR, LC-MS, HPLC, GC-MS. Microbiology: Spectrum of Antibacterial and Antifungal Activity, Biofilm Profiling, Resistance Profiling, Cytotoxicity Testing, Microscopy Services, Tissue Efficacy Modeling

K.C. Pharmaceuticals, Inc. is committed in meeting the requirements of the Current Good Manufacturing Practices (CGMP) laid out in the Code of Federal Regulations (CFR) issued by the US Food and Drug Administration (FDA). We are devoted in producing finished pharmaceuticals and medical devices that uphold high quality standards in today's consumer market. As part of our ongoing efforts in maintaining compliance, we have been keen in implementing many systems and procedures designed to improve product quality and ensure customer satisfaction. Since our manufacturing paradigm is "Building Quality Into Products," we have various internal quality control and quality assurance checkpoints through audits, inspections, reviews, and tests to guarantee that all quality requirements have been met.

Matrix Biomed, Inc. is a biopharmaceutical company focused on delivering gene-based therapeutics. Gene-based therapeutics are directed to address both the dysregulation of multiple genes as well as their interactions in gene regulatory networks. Only by addressing the dysregulation of multiple genes and their interactions in gene regulatory networks, Matrix Biomed, Inc. is able to deliver a therapy designed to truly revert a disease state to healthy state. Currently, Matrix Biomed, Inc. gene-based therapeutics are directed to therapies and drug products to make cancer treatment more manageable and successful through the elimination of the dose-limiting, life-threatening, and treatment-inhibiting toxicities associated with chemotherapy and radiotherapy while targeting the master genes responsible for cancer growth and development, hypoxia inducible factor -1 (HIF-1) and hypoxia inducible factor-2 (HIF2).

Norac Pharma is a preferred California-based API contract research and manufacturing organization offering close partnership in bringing drugs to market through excellence in process development, analytical services and cGMP manufacture of Active Pharmaceutical Ingredients (API's) & intermediates. With over 40 years of API experience, including expertise in Controlled Substances and Potent Compounds, Norac Pharma delivers timely, efficient, and regulatory-compliant service in support of your API development needs. Our excellent track record in successful project delivery along with our extensive experience justifies your confidence in our ability to deliver, irrespective of target chemistry complexity. Exceptional Chemistry - Creative Solutions

Phythera Therapeutics, Inc. was started to test, develop and improve promising small molecule-based drugs for oncology and inflammation markets. Many small bioactive phyto-molecules used in biomedicine have been derived from plants (hence –Phythera Therapeutics). The cocktail of drugs is expected to be better than one molecule for managing complex diseases with no available treatments. The only medicine which can manage HIV is a cocktail of drugs. We have something of the same magnitude but for oncology, which is viewed as “one drug- one IND” by US FDA. We see the potential of drugs carrying many small bioactive molecules to substantially improve the treatment of cancer, either as an auxiliary or even as the main treatment method. The same is true for inflammation. Optimizing and improving these small molecules to maximize their efficacy to combat metastatic cancers, and converting them into potent and robust treatments of untreatable conditions like metastatic cancer and persistent inflammation is Phythera’s main overarching goal. We leverage our expertise in 3D cell biology and transcriptomics to test the small molecule compounds to define and improve their efficacy in 3D tissue model systems, either as a single compound or as a combination of several most potent small molecule drugs. The team’s proven deep expertise in stem cell biology enables us to study the impact of our candidate molecules on the most elusive and most malignant cancer stem cells and develop drug combinations, optimized for a specific disease. Last but not least, our team has a strong interest in regenerative medicine approaches for inducing tissue regeneration and improving tissue homeostasis, the key to wellness and enduring health. Small molecule compounds derived from plants possess many of the properties promoting tissue regeneration and modulating homeostasis in tissue. Enhancing these properties and converting them into new treatments is Phythera’s 2nd overarching goal.

Headquartered in Rancho Cordova, Calif., SK pharmteco is a global contract development and manufacturing organization specializing in the production of active pharmaceutical ingredients (APIs), advanced intermediates, and cell and gene therapy for the pharmaceutical industry. SK pharmteco is comprised of six companies: SK Biotek Korea, SK Biotek Ireland, AMPAC Fine Chemicals, AMPAC Analytical Laboratories in the U.S., Yposkesi and the Center for Breakthrough Medicines.

Founded in 2004, Sundia MediTech Company, Ltd. is a leading pre-clinical contract research organization (CRO) providing a comprehensive and integrated portfolio of high-quality drug discovery and development services. Sundia's experienced R&D and international management team possess extensive experience across the fields of chemistry (custom synthesis, library design and synthesis), medicinal chemistry, biology (in vitro and in vivo), DMPK, pre-clinical studies, as well as pharmaceutical development (process research and development, API manufacturing, pre-formulation and formulation, analytical as well as QA/QC, CMC and IND filing) services. Sundia's primary research facilities, which include standard and kilo-labs, an animal facility, a pilot plant and other supporting facilities, are located in Shanghai (Zhangjiang Hi-Tech Park), Shijiazhuang and Taicang. For more information, please visit us at www.sundia.com or email us at info@sundia.com.

Turn Therapeutics® is a concept to approval pharmaceutical and medical device organization dedicated to reducing the human and economic costs of infection and skin disease. Turn Therapeutics® was founded with a goal of reducing antibiotic resistance through best in class acute and chronic wound care products. Through research and development, we have continued to uncover additional disease areas that our technology will serve. Our core mission is to leverage our expertise in drug delivery to create disruptive products for high need indications.