Business Operations


尊龙凯时AG(中国区)官方网站

01
R&D System
02
Manufacturing Facilties
03
Quality System

The company now has more than 14,000 square metres of research use area and 100 million yuan of investment in research instruments and equipment. The company 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, the company 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.

2
API R&D Centers
3
Formulation R&D Centers
1
CDMO R&D Center
01
R&D System
02
Manufacturing Facilties
03
Quality System

Huangyan site

Area (sqm):80000
Types:APIs, Intermediates, Drugs, CDMO
No. of Workshop:10
GMP / Non-GMP:GMP
Temp. Range (ºC):-20~150
Max. Pressure (MPa):0.4
Reactor Quantity:238
Reaction Vol. (L):3000~10000
Total Reaction Vol. (L):1243000

Linhai site

Area (sqm):87000
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):1993300

Jingsheng site

Area (sqm):85500
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):1059500

Binhai site

Area (sqm):80000
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):1000~6300
Total Reaction Vol. (L):1200000

Changyi site

Area (sqm):250000
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):1000~10000
Total Reaction Vol. (L):1026900

Nuode site

Since 2018
Drug Products
No. of Workshop:30
First formulation, Irbesartan tablets for the Chinese market
Current Capacity is 5.5 billion pieces
Annual production capacity of 20 billion pieces + 250 million injections available in 2024
6

Production
sites

1

Continuous large-scale
production line

2

Multi-functional flexible
production workshops

3

Key steps of products 
using pipeline reaction

1625

Reaction
equipments

8Million

Liter reaction
equipment capacity

01
R&D System
02
Manufacturing Facilties
03
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 than200 million RMB.



Regulatory Agency Certification
01
R&D System
02
Manufacturing Facilties
03
Quality System
Milestones Of Tianyu's Quality Construction History

2023

2023

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

2018

Huangyan site product 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

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