Kemwell Pvt. Ltd.,

Headquartered in Bangalore, India, Kemwell operates manufacturing facilities in India and Sweden and employs over 1000 people worldwide.  Kemwell is a 100% family-owned company, with a focus on long term strategies rather than short term goals.

We maintain a 100% commitment to pure-play contract manufacturing for our customers, which include 5 of the top 10 pharmaceutical companies in the world namely, Bayer, GlaxoSmithKline, Johnson & Johnson, Novartis and Pfizer. Kemwell has no branded products of its own in the market to avoid conflict of interests with our customers.

Meeting the dynamic needs of our clients:
In order to meet the unique and dynamic needs of each client, Kemwell has built world-class infrastructure in manufacturing, quality control and quality assurance systems, R&D labs and training facilities.  Owing to our highly flexible and adaptable organization, we currently manufacture 5 of the top 10 brands in India and supply to over 80 countries worldwide from Sweden.

Capable, Flexible and Efficient:
Contract Manufacturing is an excellent way to bring your product to market quickly and efficiently. Whether you are looking to modify an existing product, add a new product to your portfolio, or increase current manufacturing capacity, the Kemwell team is prepared with critical resources including people, facilities and equipment. With Kemwell, you will find expert solutions in product development, sourcing, manufacturing and distribution.

Our expert solutions:

• Contract manufacturer of pharmaceutical formulations for leading Multinational/ Indian pharmaceutical companies, including 5 of the top 10 pharmaceutical companies in the world
• Amongst the largest manufacturers of tablets, liquid orals, liquid oral drops, external drops, ointments and creams in India, manufacturing 5 of the top 10 brands in India
• Team experienced in USFDA/EMEA requirements
• Experience in manufacturing analgesics, antacids, antifungals /antimicrobials, anti-inflammatories, cough and cold liquids, infantcare products, nasal drops, medicated shampoos, veterinary products and wound care products in India
• Manufacture API, tablets, capsules and suppositories in Sweden

Our exciting new phase of development:
Kemwell has entered into an exciting new phase of R&D Services. We are investing to expand the breadth and depth of our services to support projects from formulation to finished products. Our labs will be equipped for formulation and analytical development, including stability studies, method development and validation, etc. In Sweden, we can also provide services for QP release. Kemwell's sites in India and Sweden can work in harmony to provide you the best solution from both worlds.

Method Development/Validation (Drug Substance, Drug Product, Excipients):

• Forced Degradation Studies
• Stability Indicating Methods
• Impurity and Degradation Product ID
• Preformulation Studies
• Method Transfers

QC Support:

• EU Gateway Release and Testing: We offer this service to companies who wish to import products into the EU and require full analytical testing and QP release
• Release Testing
• Stability Studies
• Reference Standard Qualification
• Cleaning Validation
• Microbial Testing
• Preservative Testing

Our experienced QA staff can provide quality assurance support and auditing for your internal or contracted studies. Our staff is experienced in auditing internal and external studies to assure compliance with GLP and/or GMP, as appropriate. They can also provide assistance in establishing new compliance programs.

From our modern facilities, teams of highly trained and qualified staff provide a wealth of experience to ensure high quality service is provided throughout the manufacturing process. In India, our oral solids facility has been approved by the EMEA and is ready for USFDA certification. In Sweden, the facility has been inspected by USFDA, EMEA and Japanese regulatory authorities.

Quality - the foundation of success:
Kemwell meets current Good Manufacturing Practices (CGMP) as per International Quality Guidelines and continues to invest in people, processes and equipment to ensure that Kemwell remains a quality leader in every aspect of our business. Our Quality System is the foundation of our operations and through comprehensive SOPs, rigorous training and a range of process controls, we ensure that all products meet the highest quality standards.

The Quality System:

• Quality system conforms to cGMP conditions and has WHO GMP Certification in India and has been inspected by the USFDA, EMEA and Japanese regulatory authorities in Sweden
• Facilities are fully approved and periodically audited by Corporate Quality Teams of our customers
• Encompasses all GMP related activities at the site including manufacturing, laboratory and validation
• Systems in place for deviations, complaints, change control, documentation control, CAPA, validation, pest control, training, etc.

Committed to quality compliance:
The Company is dedicated to strict cGMP compliance and the methods, facilities and controls used for the manufacture, processing, packaging and holding of all finished pharmaceuticals produced at Kemwell are in accordance with the applicable sections of cGMP regulations. A continuing employee training program, equipment and process validation, and a self-inspection program are part of our commitment to quality assurance. The entire company is committed to an ongoing quality improvement process. Special emphasis is placed on thorough documentation and review of the entire manufacturing and control process. The documentation system and customized batch documents assure that requirements have been met. These documents are reviewed and updated as necessary to maintain quality standards.

“Quality is an important part of almost all projects. We add value across the entire production chain, from buying the raw materials until the finished products leave the plant. What feels best is when we succeed with improvements, resulting in better operations".

Ensuring quality control from raw materials to the final products:
Kemwell has facilities and personnel to perform full service in-house quality control testing. Test methods include wet chemical and instrumental analyses, and microbiological evaluations.

• Raw Material and Packaging Component Testing and Release
• Microbiological Testing
• Stability Studies as per ICH guidelines
• Analytical Method Validation Services
• Cleaning and Process Validation Services
• Method Development and Validation

Our Laboratories are equipped for:

• HPLC Analysis
• GC Analysis
• Dissolution Studies
• UV Spectrophotometry
• FTIR Spectrophotometry
• Wet Chemistry
• Stability Testing

Microbiological Studies:

• Microbial Limit TestingAntimicrobial Effectiveness Testing (AET)

• Preparatory Testing

• Environmental Monitoring

Environmental Monitoring:
Design and manage comprehensive stability studies to ICH guidelines.

• 25°C ± 2°C / 60% ± 5% relative humidity
• 30°C ± 2°C / 65% ± 5% relative humidity

• 40°C ± 2°C / 75% ± 5% relative humidity

• 5°C ± 3°C
• Photo stability studies with temperature and humidity control
• Real Time Studies