Business Operations

R&D System

Manufacturing Facilties

Quality System

Tianyu now has more than 14,000 square metres of research use area and 100 million yuan of investment in research instruments and equipment. Tianyu continues to increase R&D investment, R&D investment of 276 million yuan in 2023, accounting for 10.92% of revenue. The R&D team consists of nearly 500 people, of which more than 100 have master's and doctoral degrees.

The main R&D direction involves blood pressure-lowering, blood sugar-lowering, lipid-lowering, anti-coagulation, anti-asthma, anti-virus, anti-tumour, anti-heart failure, anti-epileptic, gout, anti-prostate hyperplasia and so on. Our core technologies include grignard reaction technology, diazotisation technology, asymmetric reduction technology and heterocyclic compound synthesis.

At present, Tianyu has 109 authorized patents, including 51 national authorized invention patents, 12 authorized invention patents from the United States, Europe, Japan, India and other countries, and 46 utility model patents: 32 invention patents are in the application stage, and the number of patent applications increases by 8-12 per year.

Chemical Synthesis R&D Centers

Formulation R&D Centers

100+

Masters & PhDs

R&D System

Manufacturing Facilties

Quality System

Huangyan site

Area (sqm) : 80,000

Types : APIs, Intermediates, Drugs, CDMO

No. of Workshops : 10

GMP / Non-GMP : GMP

Temp. Range (ºC) : -20~150

Max. Pressure (MPa) : 0.4

Reactor Quantity : 238

Reaction Vol. (L) : 3,000~10,000

Total Reaction Vol. (L) : 1,243,000

Linhai site

Area (sqm) : 87,000

Types : APIs, Intermediates, CDMO

No. of Workshop : 14

GMP / Non-GMP : GMP

Temp. Range (ºC) : -80~120

Max. Pressure (MPa) : 0.4

Reactor Quantity : 398

Reaction Vol. (L) : 100~10,000

Total Reaction Vol. (L) : 1,993,300

Jingsheng site

Area (sqm) : 85,500

Types : APIs, Intermediates, CDMO

No. of Workshop : 12

GMP / Non-GMP : GMP

Temp. Range (ºC) : -70~200

Max. Pressure (MPa) : 7.4

Reactor Quantity : 180

Reaction Vol. (L) : 100~10,000

Total Reaction Vol. (L) : 1,059,500

Binhai site

Area (sqm) : 80,000

Types : Intermediates, CDMO

No. of Workshop : 10

GMP / Non-GMP : GMP

Temp. Range (ºC) : -50~200

Max. Pressure (MPa) : 1.5

Reactor Quantity : 301

Reaction Vol. (L) : 1,000~6,300

Total Reaction Vol. (L) : 1,200,000

Changyi site

Area (sqm) : 250,000

Types : APIs, Intermediates, CDMO

No. of Workshop : 30

GMP / Non-GMP : GMP

Temp. Range (ºC) : -40~180

Max. Pressure (MPa) : 2.6

Reactor Quantity : 163

Reaction Vol. (L) : 1000~10,000

Total Reaction Vol. (L) : 1,026,900

Nuode site

Production
sites

Continuous large-scale
production line

Multi-functional flexible
production workshops

Key steps of products
using pipeline reaction

1625

Reaction
equipments

8Million

Liter reaction
equipment capacity

R&D System

Manufacturing Facilties

Quality System

Quality - Trustworthy

Tianyu has been serving as our clients' most trusted partner to improve operational productivity, create competitive advantages utilizing 4 manufacturing sites certified by many of the major regulatory authorities around the world ,including FDA,EDQM, PMDA, MFDS, TGA, and NMPA.

Quality - Emphasis

Tianyu has been on a mission to supply high quality pharmaceutical products to the world. In our QC laboratory，we utilize first-class analytical instruments like Aglient, Waters, SHlMADZU and more, Over 1200 sets of QC analytical equipments , including 20+ sets of Gc MSMS and LC MSMS instruments, with an investment of more than 200 million RMB.

Regulatory Agency Certification

R&D System

Manufacturing Facilties

Quality System

Milestones Of Tianyu's Quality Construction History

2023

2022

2018

2015

2014

2013

2023

Linhai site passed USFDA inspection
Jingsheng site passed USFDA inspection
Binhai site passed PMDA inspection

2023

Linhai site passed joint EDQM/PMDA inspection
Huangyan site passed joint PMDA and TGA inspection
Huangyan site and Linhai site passed ANVISA inspection

2022

Linhai site passed TGA inspection

2018

Huangyan site-Irbesartan was approved by TGA

2015

Huangyan site passed USFDA inspection

2014

Linhai site passed PMDA in Japan and COFEPRIS GMP inspection in Mexico.

2013

Huangyan site passed EDQM on-site inspection