Based on the established advanced formulation R&D platforms, and leveraging on its competences in drug product development and manufacture, SinoT provide CRO/CDMO services for new drug candidates, including pre-formulation study, formulation and process development, clinical sample manufacturing, NDA registration batch manufacturing, quality standard establishment, and regulatory dossier document preparation and submission.
Tailored to specific drug property and different needs associated with various development stages, SinoT will provide relevant and fit-for-purpose formulation development solution and data packages, with the aims to help clients to speed up and shorten development cycle, save API consumption in early stages, and thus enable their products to reach market early and cost-effectively, bringing more benefits to patients.
SinoT offers following pre-formulation services with the aims to provide necessary data support for product development and formulation design：
Our formulation development teams are led by industry veterans，and all core team members have worked on formulation development for many years. SinoT have strong expertise and are capable of providing unique technical solutions for to meet the following f
Our professional formulation development solutions can improve the safely and in vivo efficacy performance of NCE，attain robust and controllable large-scale production and meet all regulatory compliance requirements
SinoT have successfully manufactured hundreds of batches of clinical samples/products for over 50+ clients. Those samples have been used for clinical trials across the globe, including China, the United States, Europe and Australia.
Our manufacture facility is located at Haimen of Jiangsu Province. It has successfully received and passed multiple on-site audits by FDA，NMPA and European QP. Our facility provides contract manufacturing for not only non-potent drug products, but also for highly potent drug products. It has a total of more than 25+ independent operation rooms, including formulation suites of high potency compounds. It has the process scales ranging from hundreds of grams to hundreds of kilograms, which can meet requirements of batch size from phase I to phase III clinical trials/studies.
From the wholly owned commercial manufacture facility Haimen Pharma, which is located at Haimen, Jiangsu Province, many products were manufacture and launched in the Chinese and US markets
SinoT provides following analytical services:
Our well-experienced technical team provide NMPA/USFDA filling dossier document preparation services for both domestic and oversea clients. We will also help our clients in drafting responses to the questions from regulatory agency.
As a Marketing Authorization Holder for multiple approved ANDA/NDA dossiers, SinoT has demonstrated extensive experience in regulatory filing and registration in China and USFDA. We already provided new drug NDA application services for several clients and successfully passed the on-site inspection by regulatory agency.
Shanghai Head Office
99 Haike Road, Bldg. 3, 1st Flr., Pudong District Shanghai 201210, P.R. China
Manufacturing Site in Jiangsu
No. 163 Zhuhai Road, Haimen Area, Nantong City, Jiangsu Province
