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CRO/CMO Service for NCE Candidates

Formulation Solutions to NCE candidate development
Pre-formulation services
Formulation Development
Clinical Sample Manufacturing Services
CMO for NCEs
Quality Standard Definition and Analytical Testing
Dossier Document Preparation
NDA Regulatory Registration Services

Formulation Solutions to NCE candidate development

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.


Pre-formulation services

SinoT offers following pre-formulation services with the aims to provide necessary data support for product development and formulation design:

Log P
Crystal habit (Polarized Light Microscopy)
Particle size distribution test(By shaking sieve analyzer)
Blend properties (Bulk and tapped density,Angle of repose )

Formulation Development

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

Use enabling formulation solutions to resolve issues relate to Inadequate in vivo drug exposure in preclinical animal studies
Develop formulation with speed and use API-sparing technique to limit compound consumption, and supply clinical trial sample/products that are fully complaint with GMP standard and other regulatory requirements
Resolve dissolution failures due to poor solubility of compound
Improve/elevate otherwise low oral bioavailability
Resolve poor stability problem
Resolve low compressibility
Implement new measures to improve current processes that is not robust enough or unable to scale up
Provide placebo used for clinical trial comparisons that meet the need to have same appearance with commercial products
Commercial products to be compared in clinical trials shall use blank tablets with consistent appearance

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

Dosage Form Development Capabilities
Immediate-release Tablet/Capsule
Sustained release tablet/Capsule
Enteric-coated tablet/ Capsule
Osmotic pump tablet
Bilayer tablet
Granules/Dry suspensions
Lyophilized Powder
Process Capabilities
High shear granulation
Drug layering/ Fluidized bed
Dry granulation
Hot melt extrusion
Tableting (Single layer,Bilayer,Mini-Tab,Osmotic pump)
Capsule filling(for power,pellets,Mini-Tab)
Coating(aqueous and organic solvent based coating)
Packaging (Bottle, Blister, Sachet)

Clinical Sample Manufacturing Services

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.


Special /unique formulation suites

Formulation suite for highly potent compound (covering up to OEB-5 level compound)
Low humidity formulation suite (for humidity-sensitive compound)
UV-resistant lamp(For photosensitive compound)
Labelling for clinical product(Meet various requirements of clinical trial labeling including double-blinding labelling)

CMO for NCEs

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


Quality Standard Definition and Analytical Testing

SinoT provides following analytical services:

Analytical method development and validation
Specification establishment (Combine product features and regulatory requirements)
API release testing
Excipient and Packaging material release testing
Finished product release testing
Stability study (short and long term)
Analytical Capabilities
Chromatography: UPLC, HPLC, GC, IC, CE
Solid-State Characterization: DSC, PSD, Polarized light microscope
Identification: FT-IR,UV
Routine Testing: Moisture, Solubility, LOD, Residue on Ignition
Dissolution Testing
Stability study
Microbial Limit Test
Others: ICP-MS, Viscosity, Surface Tension, Osmotic Pressure, Water Activity

Dossier Document Preparation

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.


NDA Regulatory Registration Services

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

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