One of the most critical components in the pharmaceutical value chain is drug formulation – the process of creating a stable and effective drug product from an active pharmaceutical ingredient (API). Contract Development and Manufacturing Organizations (CDMOs) have become indispensable partners in this space, providing specialized services and state-of-the-art facilities to pharmaceutical companies. At our company, we offer drug formulation CDMO services. With state-of-the-art facilities and a team of experienced scientists, we offer end-to-end and customized services including pre-formulation studies, formulation development, analytical method development and validation, scale-up and technology transfer, and manufacturing for pharmaceutical companies looking to develop and manufacture innovative drug formulations. Our commitment to quality and regulatory compliance ensures that our clients receive reliable and efficient support throughout the drug development process.
Our Services and Solutions
We pride ourselves on offering a full spectrum of drug formulation services tailored to meet the diverse needs of pharmaceutical companies. Our services include:
Pre-Formulation Studies
- Feasibility assessment
- Dosage form selection
- Excipients compatibility studies
- Solubility analysis
- Particle size analysis
Formulation Process studies
- Formulation process development
- Formulation process optimization
- Quality development
Analytical Method Development
- Method development
- Method validation
- Routine testing
- Genotoxic impurities studies
Stability Study
- Influencing factors study
- Accelerated stability study
- Long-term stability study
Scale-Up and Technology Transfer
- Pilot-scale production
- Non-GMP pilot batch production
- Process optimization
- Technology transfer
Drug Formulation Production
- Clinical sample production under GMP conditions (Phase I-II)
- Commercial production
Regulatory Submission Services
- eCTD application data preparation (NMPA, FDA, IND and NDA )
Our drug formulation CDMO services are suitable for:
- Oral Dosage Form (Tablets, capsules, granules, oral solutions/suspensions, syrups)
- Injectable Dosage Form (Injections, sterile powder for injections (sterile packaging or freeze-dried), injection solutions)
- Topical Dosage Form (Ointments, creams, liniments)
- Other Dosage Form (Eye drops, sprays, inhalants, controlled-release preparations)
Our Capacities
Specialized Production Base for Various Formulations
We have a special production base for drug preparations. The production infrastructure has a number of production workshops, each with a specific function to meet the production requirements of various dosage forms such as tablets, capsules, granules, suspensions, poultices, etc. In addition, it contains GMP warehouses that can meet various storage conditions, including 2-8 °C.
State-of-the-art Equipment
Our facility is equipped with advanced machinery designed to meet the highest standards of quality and efficiency, including but not limited to granulators and mixers, spray dryers and lyophilizers, tablet presses and capsule fillers, automated pipetting and dosing systems, encapsulation machines, etc.
High-end Formulation Research and Development Platform
At our company, we also have a professional high-end pharmaceutical formulation technology platform to keep up with the pace of innovation in drug research and development and meet the diversified requirements of customers, including sustained and controlled release formulation technology platform, insoluble drug solubilization technology platform, topical formulation technology platform, liquid formulation technology platform, soft gel technology platform, oral instant dissolve technology platform, lyophilized formulation technology platform, etc.
Our Advantages
01
Our team comprises highly skilled scientists, engineers, and regulatory experts with decades of collective experience in drug formulation and manufacturing. This expertise allows us to tackle even the most complex formulation challenges.
02
Our investment in the latest drug formulation production equipment ensures that we can deliver high-quality products with consistent results. This not only accelerates the time-to-market but also reduces risks associated with drug development and manufacturing.
03
Our end-to-end services eliminate the need for multiple vendors, streamlining the development process and ensuring seamless transitions from one phase to the next. This integration reduces costs and accelerates project timelines.
04
Our commitment to quality is unwavering. Our facilities are cGMP-compliant, and we adhere to stringent quality control measures to ensure the safety, efficacy, and reliability of our products.
Please kindly note that our services are for research use only.
