Zepatier is a once-daily oral medicine comprising 50mg of non-structural protein 5A (NS5A) replication complex inhibitor elbasvir and 100mg of NS3/4A protease inhibitor grazoprevir.
Kemwell has been providing CDMO services to pharmaceutical and biopharmaceutical clients globally for more than three decades. Kemwell scientists are specialists in dosage form development, including inhaled, nasal, oral, parenteral, and topical.
Clients include around 100 global biopharma and pharma organisations, serving seven of the world’s top ten ‘Big Pharma’ companies with development, manufacturing and distribution of small and large molecule products.
Kemwell is approved by EMA, FDA, MCC, MHRA, PMDA and TGA.
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.
Kemwell’s pharmaceutical development labs in India and US 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 US 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. Headquartered in Bangalore, we employ more than 1,200 people across our ten facilities throughout India, Sweden and in US.
Kemwell is approved by EMA, FDA, MCC, MHRA, PMDA and TGA.
Hemlibra® (emicizumab-kxwh) is an antibody indicated to reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.
Mavenclad™ (cladribine tablets) is a selective immune reconstitution therapy indicated for the treatment of active relapsing multiple sclerosis.
Duzallo (allopurinol and lesinurad) is indicated for the treatment of hyperuricemia associated with uncontrolled gout. It contains urate transporter-1 (URAT-1) inhibitor blended with xanthine oxidase inhibitor (XOI).
Developed by Janssen Pharmaceuticals, Invokamet XR (Canagliflozin / Metformin Hydrochloride Extended Release) is indicated for the treatment of Type 2 diabetes in adults.
Dysport (abobotulinumtoxinA) is an injectable formulation developed by Ipsen Biopharmaceuticals for the treatment of lower limb spasticity in paediatric patients aged two years or older.
Venclexta (Venetoclax) is an oral formulation developed by AbbVie in collaboration with Genentech and Roche, for the treatment of chronic lymphocytic leukaemia patients with 17p deletion.
Defitelio (defibrotide sodium) is an injectable drug developed by Jazz Pharmaceuticals, for the treatment of hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome, in adults and children with renal or pulmonary dysfunction following hematopoietic stem cell transplantation (HSCT).
Iomab-B is a radio-immunotherapeutic drug developed by Actinium Pharmaceuticals for treatment of refractory and relapsed acute myeloid leukaemia in elderly patients.
Abaloparatide-SC is an injectable formulation of abaloparatide developed by Radius Health for the treatment of osteoporosis in post-menopausal women.
11 Tumkur Road
Visiting address: Rapsgatan 7
SE-751 82 Uppsala
511 Davis Drive, Suite 100
United States of America