Philadelphia, PA -- (ReleaseWire) -- 01/13/2021 -- Frontida BioPharm, Inc., a pharmaceutical Contract Development and Manufacturing Organization based in Philadelphia and Chicago areas, announced today the launch of its new Category 1 (CAT.ONE™) in vitro testing and evaluation services to support development and regulatory approvals for abuse-deterrent formulations of pain management and Central Nervous System (CNS) targeted therapies.

To enable the launch of its CAT.ONE™ services, Frontida has hired a team of industry-recognized scientists with a proven track record of success in performing FDA-compliant Category 1 laboratory-based manipulation and extraction studies to support the evaluation and NDA and ANDA regulatory submission of products designed with abuse-deterrent properties. The team joining Frontida - Dr. Eric Kinzler, Chris Altomare, Greg Gironda, and Amanda Camody - previously collaborated on the design and execution of over 60 such studies involving investigational and approved abuse-deterrent products currently prescribed in the USA. To support the team, Frontida has also acquired specialized product manipulation equipment uniquely designed to simulate various abuse techniques (such as chewing, smoking, and vaping) and essential to reproducibly perform Category 1 evaluations. Frontida will leverage its established expertise in analytical development and high-throughput sample processing to rapidly deliver results for these studies.

Ron Connolly, Frontida's Executive Vice President of Business Development, Alliances and Regulatory Affairs, remarked, "Frontida's team is excited to augment our product development expertise for clients seeking to develop and commercialize new abuse-deterrent products. The scientific leadership team we have brought on board to launch our new CAT.ONE™ service offering has proven to be among the best in industry in designing and executing studies to demonstrate whether a product's formulation attributes can reduce its potential for abuse. With the team's proven track record and collective experience, we can quickly support the approval process, provide technical insight into how to incorporate abuse-deterrent properties into the formulation matrix, and help our clients navigate the regulatory and technical challenges of obtaining new approvals and product launches in important therapeutic categories. Coupled with our ability to commercially manufacture and package DEA-regulated products, Frontida can provide a high quality and reliable CDMO partnership to leading brand and generic pharmaceutical companies."

About Frontida BioPharm, Inc.
Frontida BioPharm, Inc. is a U.S. based, minority-owned CDMO providing drug delivery technologies, product development, and manufacturing services for pharmaceutical and consumer health companies. Our experts are dedicated to helping clients and partners reach the market as quickly and efficiently as possible. Frontida supports pharmaceutical companies in the development, scale-up, and commercial manufacturing of immediate and controlled-release oral solid dose, powder, and liquid products; ensuring robust product performance and on-time supply of clinical trial materials and commercial products.

Our 325,000+ sq. ft. manufacturing facilities located in Philadelphia, Pa. and Aurora, Ill. offer a comprehensive suite of solutions for the development and commercialization of prescription, OTC, Highly Potent Active compounds, Phase I through Phase III clinical trial materials, Fixed-dose Combination products, and DEA schedule II–V products. Frontida is equipped with multiple world-class commercial packaging lines, capable of validated product serialization and providing packaging services for both commercial products and clinical trial material supplies in bottles and blisters. Frontida has an annual capacity to manufacture up to 3 billion tablets and capsules. Our highly experienced, industry-leading team of professionals offers a number of available technologies and solutions that facilitate the commercialization of high-quality products.

For more information, please contact Frontida at BD@Frontidabiopharm.com or call +1 (215) 807-1350.

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Philadelphia, PA -- (ReleaseWire) -- 12/10/2020 -- Frontida BioPharm, Inc., a pharmaceutical Contract Development and Manufacturing Organization based in Philadelphia and Chicago areas, has been granted full certifiable recognition by The Eastern Minority Supplier Development Council as a Minority-Owned Business Enterprise (certified MBE).

The Eastern Minority Supplier Development Council (EMSDC) is a 501(c)(3) non-profit organization and nationally recognized affiliate of the National Minority Supplier Development Council (NMSDC). The EMSDC certifies minority-owned, operated and controlled businesses throughout Pennsylvania, Southern New Jersey, and Delaware. The NMSDC is the only organization capable of providing this specific validation and certification throughout the U.S. It advocates business opportunities for certified minority business enterprises and connects them to corporate members who maintain initiatives to support such enterprises.

Song Li, Chairman and founder of Frontida, remarked that, "We are grateful to the NMSDC for the MBE certification and to its eastern region affiliate for facilitating the selection process. From the founding of this organization, when we preserved over 150 jobs in Philadelphia and Chicago areas, to our current 214 employees, Frontida has proudly supported a diverse culture of excellence at all levels of our operations for the benefit of our personnel and our clients. We strive to devote our team's intellectual and operational capabilities to support pharmaceutical companies in bringing innovative therapies to the market."

About Frontida BioPharm, Inc.
Frontida BioPharm, Inc. is a U.S. based, minority-owned CDMO providing drug delivery technologies, product development, and manufacturing services for pharmaceutical and consumer health companies. Our team is dedicated to helping clients and partners reach the market as quickly and efficiently as possible. Frontida supports pharmaceutical companies in the development, scale-up, and commercial manufacturing of immediate and controlled-release oral solid dose, powder, and liquid products; ensuring robust product performance and on-time supply of clinical trial materials and commercial products.

Our 325,000+ sq. ft. manufacturing facilities located in Philadelphia, Pa. and Aurora, Ill. offer a comprehensive suite of solutions for the development and commercialization of prescription, OTC, Highly Potent Active compounds, Phase I through Phase III clinical trial materials, Fixed-dose Combination products, and DEA schedule II–V products. Frontida is equipped with multiple world-class commercial packaging lines, capable of validated product serialization and providing packaging services for both commercial products and clinical trial material supplies in bottles and blisters. Frontida has an annual capacity of 3 billion tablets and capsules. Our highly experienced, industry-leading team of professionals offers a number of available technologies and solutions that facilitate the commercialization of high-quality products.

For more information, please contact Frontida at BD@Frontidabiopharm.com or call +1 (215) 807-1350

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Philadelphia, PA -- (ReleaseWire) -- 12/02/2020 -- Frontida BioPharm, Inc., a pharmaceutical Contract Development and Manufacturing Organization based in Philadelphia and Chicago areas, announced today the appointment of Puneet Sapra as new Chief Financial Officer. Mr. Sapra will be replacing Andrew Wang, who recently accepted the CFO role at Frontage Holdings Corporation, a Contract Research Organization based in the USA and China (HK 1521).

Mr. Sapra joins Frontida with over 20 years of pharmaceutical and healthcare experience in executive roles at Pfizer Inc., Johnson & Johnson, Halma plc., and J.P. Morgan Chase & Co. His expertise in commercial, operational, and strategic finance comes with commendable notice as CFO of the Year from the Philadelphia Business Journal as well as industry leadership positions such as Chairperson of the Pharmaceuticals Special Interest Group of Financial Executives Networking Group. Mr. Sapra is a graduate of Harvard Business School, Duke University and London School of Economics.

Dr. Song Li, Frontida's Chairman, remarked that, "Mr. Sapra's outstanding history in healthcare, strategic planning, capital raising, innovation, and transformative technology reflect highly on both his character as a leader and his professional repute within our industry. We are certain that Puneet will help Frontida advance our corporate growth strategy as we continue to expand and implement new technologies and products in our development and manufacturing operations."

In response, Mr. Sapra commented, "I'm very excited to join Dr. Li and the entire team at Frontida. I share Frontida's passion for advancing innovation in life sciences and I hope to use my skills to help accelerate Frontida's exciting growth trajectory."

About Frontida BioPharm, Inc.
Frontida BioPharm, Inc. is a U.S. based, minority-owned CDMO providing drug delivery technologies, product development, and manufacturing services for pharmaceutical and consumer health companies. Our team is dedicated to helping clients and partners reach the market as quickly and efficiently as possible. Frontida supports pharmaceutical companies in the development, scale-up, and commercial manufacturing of immediate and controlled-release oral solid dose, powder, and liquid products; ensuring robust product performance and on-time supply of clinical trial materials and commercial products.

Our 325,000+ sq. ft. manufacturing facilities located in Philadelphia, Pa. and Aurora, Ill. offer a comprehensive suite of solutions for the development and commercialization of prescription, OTC, Highly Potent Active compounds, Phase I through Phase III clinical trial materials, Fixed-dose Combination products, and DEA schedule II–V products. Frontida is equipped with multiple world-class commercial packaging lines, capable of validated product serialization and providing packaging services for both commercial products and clinical trial material supplies in bottles and blisters. Frontida has an annual capacity of 3 billion tablets and capsules. Our highly experienced, industry-leading team of professionals offers a number of available technologies and solutions that facilitate the commercialization of high-quality products.

For more information, please contact Frontida at BD@Frontidabiopharm.com or call +1 (215) 807-1350

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Philadelphia, PA -- (ReleaseWire) -- 11/19/2020 -- Frontida BioPharm, Inc., a pharmaceutical Contract Development and Manufacturing Organization based in Philadelphia and Chicago areas, announced today the appointment of Praful Agrawala, Ph.D., as Executive Vice President, Technology. Dr. Agrawala adds years of pharmaceutical product development leadership experience to Frontida after serving in executive roles at Amneal Pharmaceuticals, Sanofi-Aventis, and Schering-Plough Research Institute.

Dr. Agrawala's core competencies include product development, discovery research interfacing, preclinical evaluation, clinical and CMC development of new chemical entities, inhalation product development, drug-device combinations development, manufacturing process development and commercialization, contract development & manufacturing, licensing, alliance management and platform technology evaluations. Dr. Agrawala joins Frontida with a noteworthy scientific background including experience in multiple dosage form development of long-acting injectables, sterile solutions, MDI and DPI inhalation products and devices, modified release tablets, rapidly disintegrating tablets, oral and nasal suspensions, oral solutions, semi-solids and transdermal products.

Anthony Qu, Frontida's COO, remarked that, "Dr. Agrawala's proven track record in developing complex formulations of long-acting and immediate release injectables, inhalation and oral dosage forms showcases his extensive background in pharmaceutics, quality and regulatory aspects of branded and generic product development. Our team is excited to have Dr. Agrawala join us during this intensive growth phase at Frontida."

In response, Dr. Agrawala commented, "I am delighted to join Frontida Biopharm at this time of tremendous growth for the company. I look forward to working with the teams at Frontida to advance the company's broad portfolio of drug delivery technologies, product development and manufacturing services for pharmaceutical companies."

About Frontida BioPharm, Inc.
Frontida BioPharm, Inc. is a U.S. based, minority-owned CDMO providing drug delivery technologies, product development, and manufacturing services for pharmaceutical and consumer health companies. Our team is dedicated to helping clients and partners reach the market as quickly and efficiently as possible. Frontida supports pharmaceutical companies in the development, scale-up, and commercial manufacturing of immediate and controlled-release oral solid dose, powder, and liquid products; ensuring robust product performance and on-time supply of clinical trial materials and commercial products.

Our 325,000+ sq. ft. manufacturing facilities located in Philadelphia, Pa. and Aurora, Ill. offer a comprehensive suite of solutions for the development and commercialization of prescription, OTC, Highly Potent Active compounds, Phase I through Phase III clinical trial materials, Fixed-dose Combination products, and DEA schedule II–V products. Frontida is equipped with multiple world-class commercial packaging lines, capable of validated product serialization and providing packaging services for both commercial products and clinical trial material supplies in bottles and blisters. Frontida has an annual capacity of 3 billion tablets and capsules. Our highly experienced, industry-leading team of professionals offers a number of available technologies and solutions that facilitate the commercialization of high-quality products.

For more information, please contact Frontida at BD@Frontidabiopharm.com or call +1 (215) 807-1350

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Philadelphia, PA -- (ReleaseWire) -- 10/27/2020 -- Frontida BioPharm, Inc., a minority-owned pharmaceutical Contract Development and Manufacturing Organization based in Philadelphia and Chicago areas, announced today the appointment of Steven Roese as Vice President of Quality. Mr. Roese joins Frontida with over 25 years of experience in quality operations and pharmaceutical industry management.

Anthony Qu, Frontida's COO, remarked about what Steve brings to the organization. "Steven's experience in multi-site quality organizations is an invaluable asset to Frontida's operational contributions. His demonstrated history of commitment to improving procedural effectiveness and the consistency of product manufacturing will undoubtedly help Frontida surpass both current and new milestones."

Mr. Roese's professional engagement within the pharmaceutical industry features proven excellence in the management of GMP Operations, Compliance, Quality Systems, GCP/GLP oversights, and product manufacturing. In addition, he has overseen the successful launch of commercial drug products and the development of clinical trial programs. Effective immediately, Mr. Roese will be responsible for Frontida's performance metrics, system audit standards, Quality Assurance, and Quality Control operations, replacing Jane Wong, who has retired after 4 years of dedicated service to Frontida.

"The Frontida team is very pleased to have Steve Roese join us as the new VP of Quality. His diverse quality background and global experience will provide the required quality leadership as we expand our manufacturing and product launch goals while maintaining a continuous improvement mindset." – Renard Jackson, EVP Contract

Operations

About Frontida BioPharm, Inc.
Frontida BioPharm, Inc. is a U.S. based, minority-owned CDMO providing drug delivery technologies, product development, and manufacturing services for pharmaceutical and consumer health companies. Our experts are dedicated to helping clients and partners reach the market as quickly and efficiently as possible. Frontida supports pharmaceutical companies in the development, scale-up, and commercial manufacturing of immediate and controlled-release oral solid dose, powder, and liquid products; ensuring robust product performance and on-time supply of clinical trial materials and commercial products.

Our 325,000+ sq. ft. manufacturing facilities located in Philadelphia, Pa. and Aurora, Ill. offer a comprehensive suite of solutions for the development and commercialization of prescription, OTC, Highly Potent Active compounds, Phase I through Phase III clinical trial materials, Fixed-dose Combination products, and DEA schedule II–V products. Frontida is equipped with multiple world-class commercial packaging lines, capable of validated product serialization and providing packaging services for both commercial products and clinical trial material supplies in bottles and blisters. Frontida has an annual capacity to manufacture up to 3 billion tablets and capsules. Our highly experienced, industry-leading team of professionals offers a number of available technologies and solutions that facilitate the commercialization of high-quality products.

For more information, please contact Frontida at BD@Frontidabiopharm.com or call +1 (215) 807-1350.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Philadelphia, PA -- (ReleaseWire) -- 08/18/2020 -- Philadelphia, Pennsylvania, U.S.A. August 18, 2020 Frontida BioPharm, Inc. today announced the completion of a facility expansion to their oral solid dose manufacturing operations with the commissioning of a Highly Potent Compound Contract Manufacturing Suite. This addition features 1000 sq. ft of readily available, hazard-certified production space.

Key service equipment and set-ups include a large scale Roller Compactor, Milling Room, Bin Blender, Tablet Press, and ingress and egress airlocks with enhanced personnel controls. Frontida will utilize these capabilities to streamline clients' goals for the development of flexible and scalable manufacturing processes for clinical trial materials through commercial product operations.

Highly potent compounds serve an increasingly significant role in numerous R&D landscapes and pharmaceutical intensive medical treatments; i.e. oncology, atrial fibrillation, osteoporosis. In order to produce these products, a thorough process of product risk analysis is required in order to maintain a consistent manufacturing balance between production scale, market distribution and demand requirements. As a key step to utilize this new suite, Frontida's manufacturing assessments will verify each highly potent compound's level of toxicity, potential personnel and facility exposure limitations.

"The addition of a highly potent suite at Frontida Biopharm, Inc. leverages the internal know-how and capabilities of our existing product development and manufacturing teams. The expert personnel leading this 'suite' new expansion contribute an average of 20 years practical experience to every project. Each prioritizes the safety and well-being, OEL guidelines, effluent containment practices, responsible air emissions, and sanctioned waste removal needed in order to better serve our pharmaceutical clients." ~ Anthony Qu Ph.D, Chief Operating Officer

"This area will expand Frontida's capabilities to our customers, further assuring that our culture of excellence and production quality is maintained through high grade service options, and top-of-the-line technological advantages." ~ Renard Jackson, Executive Vice President of CMO Services

About Frontida BioPharm, Inc.
Frontida BioPharm, Inc. is a US-based, minority-owned leading provider of drug delivery technologies, product development, and manufacturing services for pharmaceutical and consumer health companies. Frontida is dedicated to helping our clients and partners reach the market as quickly and efficiently as possible. We support pharmaceutical companies in the development, scale-up and commercial manufacturing of immediate and controlled-release oral solid dose, powder and liquid products; ensuring robust product performance and on-time supply of clinical trial materials and commercial products.

Our 325,000+ sq. ft manufacturing facilities located in Philadelphia, PA and Aurora, IL offer a comprehensive suite of solutions for the development and commercialization of prescriptions, OTC, Highly Potent Active Ingredient (HPAI) products, Phase I through Phase III clinical trial materials, Fixed-dose Combination Products and DEA schedules II – V products. Frontida is equipped with multiple world-class commercial packaging lines, capable of validated product serialization, and providing packaging services for both commercial products and clinical trial material supplies in bottles and blisters. Frontida has an annual capacity to manufacture up to 3 billion tablets and capsules. Our highly experienced industry-leading team of professionals offer a number of available technologies and solutions that facilitate the commercialization of high-quality products.

For more information on this press release visit: http://www.releasewire.com/press-releases/release-3.htm

Philadelphia, PA -- (ReleaseWire) -- 06/22/2020 -- FB-HRS, LLC today announced the US Food and Drug Administration has cleared an Investigational New Drug (IND) application to initiate its Clinical Trial of FBHRS001, a fixed dose combination (FDC) of two drugs, for the treatment of atrial fibrillation. This FDC product is being evaluated for the improved safety and efficacy, in comparison to existing drugs on the market.

Atrial fibrillation is the most common sustained abnormal heart rhythm that affects over 9.3 million people in the United States, over 13 million people in China, and over 30 million people world-wide.

FBHRS001 has been developed through a collaboration between FB-HRS, LLC and Zhendong Pharmaceutical Co., Ltd. to address the efficacy and safety concerns of existing medicines in the atrial fibrillation market today. While most drugs prescribed face challenges with serious adverse effects, such as thyroid dysfunction, liver injury, or sudden cardiac death from induced Torsades de pointes, FBHRS001 has the potential to provide a reduction in adverse effects while being effective in the treatment of atrial fibrillation.

About FB-HRS, LLC
FB-HRS, LLC is a joint venture, co-founded by Frontida BioPharm, Inc. and Heart Rhythm Solutions, Inc., both located in Philadelphia, U.S.A. FB-HRS, LLC focuses on research, development and commercialization of innovative medicines for the treatment of cardiovascular diseases.

About Frontida BioPharm, Inc.
Frontida BioPharm, Inc. is a leading provider of drug delivery technologies, product development and manufacturing services for both small and large pharmaceutical and consumer health companies. Frontida BioPharm is helping our clients and partners reach the market faster, ensuring robust product performance and on-time supply of clinical and commercial products. Our 300,000+ sq.ft manufacturing facilities supply prescription and OTC products, Highly Potent Active Ingredient (HPAI) products, Fixed-dose Combination Products and DEA schedules II – V products. Our three state-of-the-art facilities, two located in Philadelphia, PA and one located in Aurora, IL with 4 commercial packaging lines, equipped with validated product serialization technology, provide packaging services for both commercial products and clinical trial material supplies.

Visit: (https://www.frontidabiopharm.com/)

About Heart Rhythm Solutions, Inc.
Heart Rhythm Solutions is a research based company focusing on preclinical and clinical research for the treatment of cardiac diseases. It has an advanced platform to quickly and effectively screen for drug-related cardiac safety and potential drug targets in the treatment of cardiac arrhythmias.

About Zhendong Pharmaceutical Co., Ltd.
Zhendong Pharmaceutical Co., Ltd. is a leading publicly traded high-tech enterprise integrating research, development, manufacturing of APIs and finished products for both Western medicine and traditional Chinese medicine. Zhendong's products cover broad therapeutic areas, including oncology, cardiovascular, anti-infectious, gastrointestinal, respiratory areas, etc.

Visit: (http://en.zdjt.com/)

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