Kemwell

Contract Manufacturing and Development, Packaging and Global Distribution

Kemwell is a contract development and manufacturing organisation serving the pharmaceutical industry, offering both small and large module production, development, and global distribution.

Kemwell's scientists have strong experience in dosage form development, including parenteral, topical, oral, nasal, and inhaled. Its sterile and non-sterile product portfolio ranges from pre-formulation to worldwide commercial supply. Kemwell is approved by the EMA, TGA, FDA, PMDA, MHRA, and the MCC.

With ten facilities in India, Sweden and the US, Kemwell's workforce of 1,200 serves more than 100 clients from the pharmaceutical and biopharmaceutical sectors. In 2006, Kemwell acquired a site in Uppsala from Pfizer. It later acquired product development organisation Cirrus in 2013, which allowed for global collaborations, providing manufacturing, product development and task-based services.

EU gateway release testing

The majority of dose forms we offer today, which marry European and Asian strengths, are: solid dose tablets; uncoated, sugar-coated and film-coated (solvent and aqueous) tablets; suppositories; effervescent and bi-layer tablets; hard gelatin capsules filled with powder, granules, pellets or liquid-orals; semi-solid creams, gels and ointments; and controlled and psychotrophic drug substances.

Our common biopharmaceutical facility (15,000m²) for large molecules in Bangalore offers services such as full-service process development, manufacture, formulation, and fill and finish. The cGMP manufacturing facility is a one-stop-shop, with access to large-scale commercial production.

Drug formulation development, stability studies, clinical batch production and manufacturing

Kemwell has the experience, expertise and infrastructure in place to meet your every need. Discover how our development and manufacturing solutions can keep you competitive. They include:

  • Quality: guarantee the highest standards of quality and compliance; benefit from high customer service levels
  • Speed: reduce time between drug development and commercialisation; shorten lead times for an efficient supply chain
  • Value: do more with less in R&D and manufacturing; innovate to streamline manufacturing

Whether you are looking for pre-formulation studies, formulation development, stability studies, analytical support, clinical batch production, commercial-scale manufacturing or packaging, Kemwell is the ideal partner for you.

Through collaboration and innovation, Kemwell meets every challenge successfully, refusing to rest until the customer is satisfied.

Pharmaceutical process facilities

Our Swedish facilities have over 50 years of experience in supplying pharmaceutical products. Our core process technologies include wet and dry granulation, compaction, blending and high shear mixing, fluid bed drying, tablet pressing, capsule filling, semi-solid moulding, coating and vision inspection.

QP release services for pharmaceutical products

We also provide QP release services for Europe for products manufactured at our site or outside the EU, thereby covering the full chain of QA responsibility for API and finished products. We have been inspected by USFDA, EU and Japanese regulatory authorities, and supply to over 80 markets worldwide.

Spread over 14,000m², our Swedish facilities are capable of expanding and adapting quickly to meet the high demands of the customer.

 

Oral solids, liquids and semi-solids facilities

Kemwell’s new oral solids facility is a state-of-the-art facility built in Bangalore to manufacture up to five billion tablets and capsules for global supply. Covering over 15,000m², the facility has been designed to marry flexibility with stringent measures for contamination control.

Kemwell’s liquids facility has been supplying to customers since 1995 and has benefited from continuous investments in process improvements and expansions. We are now building a new liquids facility to increase our manufacturing capacity.

Kemwell’s semi-solids facility has been operational since 2001. We manufacture gels, ointments, creams and solutions for various topical and ophthalmic applications.

  • Blisters: ALU-PVC, ALU-PVC/PVDC, ALU-Aclar, ALU-ALU, ALU/PE-ALU/PE, ALU-Triplex (COC/PVC/PVDC)
  • Containers: glass bottles, plastic bottles, aluminium and plastic tubes
  • Sachets / pouches
  • Blister packing including child-resistant packs
  • Bottle packing in various sizes with CRC, press-fit and screw capping capability
  • Controlled and psychotropic drug substances can be handled

Quality contract manufacturing, development services, packaging and global distribution

Kemwell meets cGMPs as per international quality guidelines, which ensures that all products meet the highest quality standards. We continue to invest in people, processes and equipment to ensure that Kemwell 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, to ensure that quality is the foundation of our success

Contact Details

Kemwell Biopharma Pvt. Ltd.
Kemwell House
11 Tumkur Road
Bangalore 560022
India
+91 80 3928 6200
+91 80 2337 9152
Info.India@Kemwellpharma.com
www.kemwellbiopharma.com

Available White Papers

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Kemwell: Keeping You Competitive 21 November 2014 Kemwell is a 100% customer oriented company with expertise in contract development and manufacturing services for pharmaceutical and biopharmaceutical products.

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