ABOUT BORA PHARMACEUTICALS

Bora Pharmaceutical is a premier international CDMO specializing in oral solid dosage pharmaceutical Rx and OTC products for late phase Clinical through Commercial manufacturing and packaging. Our facilities are USFDA, MHRA and TFDA approved. What makes us unique is our ability to handle routine to complex solid dosage forms (tablet and capsules) including immediate release, controlled/extended release, extrusion/spheronization, bilayer tableting, tray drying, solvent handling, film coating, and much more. Our packaging lines are fully serialized.

Currently, Bora has 2 state-of-the-art cGMP manufacturing facilities built to the highest international standards for manufacturing, packaging, R&D, and analytical testing. Our manufacturing facilities have also been inspected by the Jordan FDA and GCC (Gulf Cooperation Council) with approved sales to over 17 countries worldwide including the US, EU countries, Southeast Asia, Middle East, and Central America. Both sites are TAA approved.

At Bora, reliability, integrity, and innovation are at the core of every product we touch. That is why we are dedicated to offering reliable, personal service that begins with proactive project management and technical support, that results in consistently high-quality product and complete fulfillment of your global outsourcing goals.

FEATURED SERVICES

Bora Pharmaceutical Laboratories is a certified drug product manufacturer by Taiwan FDA, U.S. FDA and MHRA which complies with the PIC/S GMP and GDP for drug products, and the authorized operations for manufacturing and packaging non-sterile products for solid dosage form including film-coated tablet (tablets, granules, powder) and capsules.

Bora has packaging facility to package sachets (Tainan), blisters (Tainan), tablet and capsule products. The entire packaging area is divided into primary and secondary packaging areas. Primary packaging area is designed to meet ISO 8 requirement for finished products are packed into bottles with desiccants, sealed and capped. Packaging rooms, gowning rooms, and support rooms (equipment cleaning, drying and storage rooms) are physically separated and cascade of pressurization system is used to control dust migration and prevent cross contamination.

Bora formulation development team provides formulation development and solution from an early stage of new chemical entities (NCE) to generic products.

Bora provides customized analytical solutions for small molecules. Depending on product development phases, and global relevant regulatory guidance (ICHFDAUSPEP, JP etc.), Bora designs customized analytical solutions utilizing state of the art equipment, and performs under GMP environment specifically targeting your need.  Bora is also equipped with Empower 3 software to ensure data integrity.

Our expertise in technology transfer and scale up ensures that the final product will be suitable for large scale manufacture and commercialization. We can provide small-scale proof of concept prototype batches, manufacture clinical trial materials; perform scale up manufacturing and registration batch manufacturing as well as perform product transfer and validation services in preparation for Commercial Manufacturing

CONTACT INFORMATION

Bora Pharmaceuticals

1000 N. West Street, Suite 1200

Wilmington, DE 190801

UNITED STATES

Phone: 1-866-6PHARMA

Contact: Sam Ricchezza

FEATURED ARTICLES

  • Pharmaceutical Outsourcing And Planning In A COVID World

    Firms need to innovate, change, and have in place quality risk management strategies to develop and implement action plans and knowledge transfer programs to ensure the production of safe and effective medicines in times of staff shortages.

  • What Is The Status Of Drug Intellectual Property (IP) In Taiwan?

    One of the biggest concerns about working in Asia by North American drug companies is the sanctity of their Intellectual Property (IP).  Will it be copied and then all the hard work, years of time and money invested lost?  This article gives insight into the Taiwan IP Office and its processes.

  • The Benefits Of Converting Waste Heat To Create Sustainable Steam Systems In Your Pharmaceutical Manufacturing Plant

    A pharmaceutical manufacturer discovered that some steam mixed within the condensate and that steam was inefficiently released to the atmosphere. Read how they discovered a way to recycle the waste steam to preheat the process hot water system and which resulted in several improvements.

  • Ahead Of The Curve: Pharma Preparing For A Post COVID-19 World

    ‘Business Preparedness’ is a term rarely used outside the boardroom, but in light of the COVID-19 crisis, it’s gaining new relevance. Currently, it’s on everyone’s agenda and at the forefront of most internal meetings.

  • How To Control And Modify The Release Of Today’s Insoluble, Potent APIs

    Synchronizing and controlling API delivery, extrusion-spheronization is a robust technique offers pharmaceutical companies a reliable, efficient way to manufacture today’s most effective patient-centric therapeutics.

  • How Extrusion-Spheronization Can Help To Control Delivery And Enhance Performance Of Complex Therapies

    In this blog, we explore why and how the technique of extrusion-spheronization offers pharmaceutical companies a robust, proven way to manufacture today’s most complex therapies. We also discuss the key considerations for drug developers who are looking to select a contract manufacturer as a partner to deliver this technique.

  • How To Minimize Production Downtime By Maintaining Your Tablet Compression Tooling

    Optimizing and maintaining tablet compression tooling surely brings challenges. Poorly performing tools are a challenge all pharmaceutical manufacturers have to conquer. This blog reviews how to reduce common compression issues during production and eliminate tooling downtime and offers tips on how to extend the life of your tablet compression tooling.

  • How Can You Get Two Or Three APIs To Play Nice In One Capsule?

    Oral solid dose (OSD) delivery remains the most popular route for administering drugs. Market forces are prompting pharmaceutical companies to pursue a broad array of OSD development strategies to make their active pharmaceutical ingredients (APIs) and formulations therapeutically effective and patient friendly. One choice that is growing in popularity to control dose frequency and side-effects are compressed, tablet form multiple-unit pellet systems (MUPS).

  • Extrusion- Spheronization, Engineered For Today’s Controlled Release Forms

    Synchronizing and controlling API delivery, extrusion-spheronization offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. With the right capabilities, this well-understood process stands ready to help lead the development and manufacturing of both today’s and tomorrow’s complex OSD therapeutics.

  • Bora's responsibility To navigate COVID-19

    As the world is fighting to contain the COVID-19 (the coronavirus), I wanted to reach out and provide an update on the actions that Bora is taking to prevent the spread of the virus, ensure business continuity, and support the health and well-being of our customers, employees and communities.

  • Bora Pharmaceuticals To Acquire GSK Mississauga-Based Facility

    Bora Pharmaceuticals Co., Ltd  (6472.TWO) and GSK announced today they have entered into an agreement under which Bora Pharmaceuticals will acquire GSK's Mississauga, Ontario (Canada) facility. 

  • Bora Appoints President To Strengthen North American Team

    Bringing over 25 years’ CDMO experience to the team, Ricchezza is the former president for WellSpring Pharma Services and has held several senior roles at some of the industry’s most prominent contract service companies such as Patheon and AAIPharma (Alcami).

  • Fast-Growing CDMO Opens U.S. Office

    The Asia-Pacific (APAC)-headquartered CDMO, which has invested over $60 million in acquiring world class facilities in recent years, has established the office as part of its two-year plan to invest in the North American market.

  • Bora Secures FDA Approval For CDMO Services

    Bora, a contract development and manufacturing organization (CDMO) that specializes in modified release (MR) and solvent production, has reported a successful FDA general inspection for its facility in Zhunan, Taiwan.