Taiwan's biggest CDMO secures FDA approval3 Sep 2019
Customers claim Bora's oral solid dosage Zhunan facility is in the top 5 external manufacturing facilities they’ve ever visited in the world.
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.
The publicly listed company recently hosted the site’s fifth successful inspection by the US regulatory body of its global supply facility located south-west of Taipei, with zero 483 observations.
The oral solid expert is Taiwan’s biggest CDMO, responsible for producing 52% of finished dosage form exports from Taiwan to the US and 11% from Taiwan to ROW. Its customers include some of the largest multinational pharmaceutical companies in the world.
Bobby Sheng, CEO at Bora Pharmaceuticals, commented: “Since acquiring this facility in early 2018, we have built a phenomenal team that is dedicated to adhering to strict quality standards. In fact, over 25% of the site’s workforce is devoted to quality assurance and control, so this approval is testament to them and the rest of our team.
“This latest FDA inspection underlines our commitment to servicing the US market and supporting our own future growth strategy. Our customers consistently praise our quality standards and efficiency, often saying the facility is in the top 5 external manufacturing facilities they’ve ever visited in the world.
“We now intend to invest further into our US growth strategy to continue to be the most agile CDMO partner we can be.”
The Zhunan facility is also licensed by the MHRA, TFDA and is PIC/S certified. The site employs over 300 people and also offers small-scale R&D capabilities to support clients across all stages of the product lifecycle.
Sheng continued: “The advantages of modified release drugs are becoming increasingly recognized across the industry. Our ability to meet that growing demand with large-scale solvent manufacturing and at the same time handle complex drug products such as fixed dose combination products (FDC) at commercial scale has been a major advantage for us and a huge benefit to our customers.”
With a broad range of manufacturing technologies at its sites, Bora provides development to large-scale manufacturing, packaging, distribution, tech transfer, stability studies, and product life cycle management.
Thermo Fisher Scientific signs agreement with Lilly Oncology for companion diagnostic
10 Sep 2019
Strategic agreement utilizes FDA-approved next-generation sequencing Oncomine Dx Target Test to identify RET-altered NSCLC and thyroid cancer patients who may be suitable for Lilly's RET inhibitor.Read more
FUJIFILM Irvine Scientific launches BalanCD Gal Supplement for biotherapeutic development
10 Sep 2019
Delivers enhanced galactosylation for improved protein quality, and antibody binding and function.Read more
Drivers behind Saudi Arabia’s forecast 10.74 $billion 2022 market
9 Sep 2019
Growing population, increase in non-communicable diseases and major investment in new hospitals, clinics and treatments driving growth.Read more
Catalent to open new clinical supply facility in San Diego
6 Sep 2019
Will enhance speed to clinic through expanded early-phase clinical supply and oral dose development services.Read more
Take part in pharma’s largest reputation survey
6 Sep 2019
Use your voice to shape CPhI Worldwide's third annual global survey of the major trends, changes and developments in the industry.Read more
BioCity backs world's first Rx to OTC switch incubator
5 Sep 2019
Maxwellia considered to have the skills and the expertise to deliver and reach their goal of creating the big OTC brands of the future.Read more
Velesco Pharma to triple its clinical manufacturing capacity
4 Sep 2019
Company's new building in Wixom, MI replace and consolidate its existing manufacturing site in Kalamazoo, MI.Read more
China relaxes import regulations to improve access and availability of affordable medicines
3 Sep 2019
The potential for generics to support the healthcare needs of China is significant.Read more
Dutch company receives €20 million for skin cancer diagnostic test
3 Sep 2019
The test can accurately predict the risk of having metastases present in the lymph nodes without having to undergo surgery to remove lymph nodes.Read more
Sandoz enters global deal to commercialise proposed biosimilar natalizumab
2 Sep 2019
Worldwide agreement with Polpharma gives Sandoz commercialization rights to proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation