Kemwell is a full service provider and a 100% customer-oriented company with extensive expertise in contract manufacturing and development services for pharmaceutical products. With Kemwell you will find expert solutions in product development, sourcing, analytical support, clinical batch production, commercial-scale manufacturing and packaging solutions, with distribution from facilities that are certified by USFDA, EU and Japanese regulatory authorities.
Pharmaceutical development labs
Kemwell’s pharmaceutical development labs in India and Sweden are led by a management team with the necessary experience, scientific knowledge, vision and steadfast commitment to meet customers’ needs. The management team guides Kemwell’s scientific workforce, which is composed of highly experienced and well-qualified professionals who spearhead resources from India and Sweden to find the best solution for you.
Formulation and analysis for dosage forms
Kemwell’s experienced scientists have developed formulations and analytical methods for conventional and specialised dosage forms.
Analytical testing methods are designed to meet your exact specifications, while supporting rapid development timelines. To convert your potential into a product, we offer a wide range of services: formulation and process development, development and validation of analytical methods, clinical supply, scale-up, process validation, and stability studies in accordance with the relevant guidelines (such as ICH). We can support your outsourcing needs from discovery to clinical supplies to regulatory filing, guaranteeing quality, speed and value. East and west combine to find you the perfect solution.
Oral healthcare R&D
In 2008, Kemwell set up a new R&D facility in Bangalore, India, in partnership with one of the world’s leading pharmaceutical companies – a successful collaboration. This R&D centre has been set up to cater to clients’ global oral healthcare development projects, with the facility and staffing put in place by Kemwell in six months.
Kemwell was selected by the client owing to our senior management commitment to diversification and innovation, our ability to deliver a new GMP facility and skilled manpower, and our commitment to planning, delivery and quality. Discover how we can collaborate with you to meet your needs too.
EU gateway release testing, stability studies, and transfer of analytical methods
Our development services include:
- New formulation development
- Analytical method development and validation
- Transfer of analytical methods
- Stability studies (as per ICH guidelines)
- Microbiology services (MLT, PET and sterility testing)
- Process development / scale-up
- Raw material and packaging component testing and release
- Clinical supplies
- Dossier preparation
- EU gateway release testing - QP release
cGMP pharmaceutical contract manufacturing and development
Kemwell meets cGMPs as per international quality guidelines, and continues to invest in people, processes and equipment to ensure that it remains a quality leader in every aspect of its business, and that quality is the foundation of its success.
Our quality policy is:
- To apply the principles of quality assurance to all activities and systems, with continuous evaluation and improvement with a view to achieve consistent standards of quality
- To ensure that all personnel in the organisation are committed to maintaining corporate and customer quality requirements in every aspect of business
- To comply with all statutory regulations of the local authorities as well as those applicable to all markets to which the products are being supplied
We are dedicated to strict cGMP compliance; the methods, facilities and controls used for manufacturing, packaging and holding of all finished pharmaceuticals produced at Kemwell are in accordance with global cGMP regulation, ensuring that all products meet the highest quality standards.
Special emphasis is placed on thorough documentation and review of the entire manufacturing and control process.
Kemwell is a leading pharmaceutical contract development and manufacturing company with headquarters in Bangalore, India, and manufacturing facilities in India and Sweden. We provide packaging and global distribution for five of the top ten pharma companies of the world.