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 19801

UNITED STATES

Phone: 1-866-6PHARMA

Contact: Sam Ricchezza

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