Taiwan's biggest CDMO secures FDA approval
![](/46/pdcnewsitem/07/96/83/Bora%20Zhunan%20facility%20%20(1).jpg)
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.
![Bora Pharmaceuticals Laboratories Inc.](https://www.cphi-online.com/c280920th_S-comp280920.jpg)
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance