Taiwan's biggest CDMO secures FDA approval

3 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.

Taiwan's biggest CDMO secures FDA approval

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.

Read More

Related news

New microbial air sampler addresses continuous monitoring

New microbial air sampler addresses continuous monitoring

14 Nov 2019

The device supports the new EU GMP Annex 1 requirements.

Read more 
GVK Bio continues to see growth tailwinds for 2020 thanks to a ‘crescendo of factors’

GVK Bio continues to see growth tailwinds for 2020 thanks to a ‘crescendo of factors’

13 Nov 2019

China-US trade challenges has led to de-risking by pharma companies.

Read more 
Winners of the 16th Pharma Awards

Winners of the 16th Pharma Awards

11 Nov 2019

Companies and individuals from across the whole pharma supply chain recognised for their excellence and commitment.

Read more 
CDMOs to benefit from rising BTDs, orphan drugs and fast track status therapies

CDMOs to benefit from rising BTDs, orphan drugs and fast track status therapies

8 Nov 2019

But personalized medicines will require new logistics and manufacturing systems.

Read more 
SGH Healthcaring unveils its new asthma spacer device

SGH Healthcaring unveils its new asthma spacer device

8 Nov 2019

Zephyr's revolutionary new design improves drug administration and simplifies treatment delivery for better observance.

Read more 
Recipharm expands Indian injectable dosage form capabilities

Recipharm expands Indian injectable dosage form capabilities

7 Nov 2019

Partnership will combine capabilities and expertise in Europe and India to build a new facility dedicated to injectable formulations to supply demand from Europe and overseas territories.

Read more 
Aptar acquires a leader in drug delivery training devices and patient onboarding

Aptar acquires a leader in drug delivery training devices and patient onboarding

6 Nov 2019

Acquisition reflects movement of treatments being administered by patients at home rather than by healthcare providers.

Read more 
Europe predicted to surpass the US in biologic manufacturing capacity by 2023

Europe predicted to surpass the US in biologic manufacturing capacity by 2023

6 Nov 2019

Demand for biological manufacturing is growing faster than capacity growth.

Read more 
SP acquires Spain based global provider of complete sterile filling lines

SP acquires Spain based global provider of complete sterile filling lines

5 Nov 2019

Company's strategic move reflects its expectation of short-run aseptic liquid filling to continue to drive pharmaceutical growth.

Read more 
Legacy recruits heavily to meet growing steriles demand

Legacy recruits heavily to meet growing steriles demand

5 Nov 2019

Company to reach 250 employees by year end to meet growing drug product manufacturing demand.

Read more