Kemwell Pharmaceutical Contract Development, Manufacturing, Packaging and Distribution
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.
Products and Services
Juluca (Dolutegravir and Rilpivirine) for the Treatment of HIV-1 Infection
Zepatier for the Treatment of Chronic Hepatitis C Genotype 1 and 4 Infection
Hemlibra® (emicizumab-kxwh) for the Treatment of Haemophilia A with Inhibitors
ILUMYA for the Treatment of Moderate-to-Severe Plaque Psoriasis
Mavenclad (cladribine tablets) for the Treatment of Relapsing-Remitting Multiple Sclerosis
Duzallo (allopurinol and lesinurad) for the Treatment of Hyperuricemia Associated with Gout
Tremfya (guselkumab) for the Treatment of Plaque Psoriasis
Invokamet XR for the Treatment of Type 2 Diabetes in Adults
Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Paediatric Patients
Venclexta (Venetoclax) for the Treatment of Chronic Lymphocytic Leukaemia
Defitelio (defibrotide sodium) for the Treatment of Hepatic Veno-Occlusive Disease
Iomab-B for the treatment of Refractory and Relapsed Acute Myeloid Leukaemia
Abaloparatide-SC for the Treatment of Post-menopausal Osteoporosis
Evotaz (atazanavir and cobicistat) for the Treatment of HIV-1 Infection
Cirrus Pharmaceuticals has announced it is ready to launch its services for manufacturing cGMP materials for early phase clinical trials in its state-of-the-art flexi-suite at its Raleigh-Durham, US, site.Read more
Cirrus Pharmaceuticals has announced it will be investing in a flexible current good manufacturing practice (cGMP) suite in its facility in Research Triangle Park (RTP), North Carolina.Read more
Kemwell AB, part of the Kemwell group, which is a contract pharmaceutical development and manufacturing company with facilities in Sweden, India and the US, has announced the appointment of Mikael Ericson as the new CEO of its Swedish operations.Read more
Mikael Ericson will be the new CEO of Kemwell's Swedish operations.Read more
Siddharth J Advant, PhD, is the new president of its biopharmaceutical services.Read more
Bangalore-based Kemwell Biopharma has announced the acquisition of US-based Cirrus Pharmaceuticals, which specialises in contract development services.Read more
Kemwell today signs an agreement with Mercury Pharma Group for contract manufacture of pharmaceuticals in the new state-of-the-art production facility in Uppsala.Read more
Kemwell Biopharma's oral solids facility in Bangalore has been in operation since 2008 and received its first EMA approval in 2008. Kemwell is pleased to announce that it has recently received approval from Health Canada to manufacture and supply oral solid dosage products from the facility to the Canadian market.Read more
The India-based formulations contract manufacturer, Kemwell Biopharma Pvt. Ltd., has expanded its state-of-the-art pharmaceutical development labs in Bangalore, including a 7,500 sq ft cGMP pilot facility to support pharmaceutical projects from pre-formulation to finished products.Read more
Kemwell, a leading provider of contract development and manufacturing services, has won the OPPI Best Vendor Award 2010 for Contract Manufacturing. The Organisation of Pharmaceutical Producers of India (OPPI), established in 1965, is a premier association of research-based international and largeRead more
Kemwell to Build Biopharmaceutical Manufacturing Facility in India in Collaboration with Boehringer Ingelheim
In a groundbreaking ceremony, Kemwell has completed construction of a new biopharmaceutical manufacturing plant in Bangalore, India, a strategic collaboration with Boehringer Ingelheim, Germany. With this collaboration, Kemwell will complement its early clinical supply services rangingRead more
Kemwell, a leading pharmaceutical contract development and manufacturing company, will be attending the BioPharma India Convention 2010 in Grand Hyatt Mumbai, Mumbai, India, taking place on 6-8 December 2010. We look forward to seeing you at the convention.Read more
Kemwell, India's leading pharmaceutical contract manufacturer, has set up a new R&D facility in Bangalore, India, in partnership with the world's leading pharmaceutical company, GlaxoSmithKline (GSK). This R&D centre has been set up to cater to GSK's global oral healthcare development proRead more
Kemwell has started constructing a new non-sterile liquid facility in Bangalore to meet the region's increasing demand. Kemwell is one of India's largest liquids manufacturers, having been supplying to customers such as GSK and Pfizer for decades. Scheduled for completion in May 2011,Read more
The family owned company group Kemwell in India acquired one of Pfizer's factories in Sweden during 2006 and by this transaction established itself as a contract manufacturer in the EU market. Owing to strong company development, Kemwell has now decided to increase its production capacity by expaRead more
11 Tumkur Road
Visiting address: Rapsgatan 7
SE-751 82 Uppsala
511 Davis Drive, Suite 100
United States of America