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 European Medicines Agency (EMA), Therapeutic Goods Administration (TGA), Food and Drug Administration (FDA), Pharmaceuticals and Medical Devices Agency (PMDA), Medicines and Healthcare products Regulatory Agency (MHRA), and the Medicines Control Council (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 also 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 Kemwell offers today 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.

The company’s common biopharmaceutical facility (15,000m²) for large molecules in Bangalore offers services such as full-service process development, manufacture, formulation, and fill / finish. The current good manufacturing practice (cGMP) production 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 these development and manufacturing solutions can keep you competitive. They include:

  • Kemwell guarantees the high standards of quality and compliance, so you can benefit from high customer service levels
  • Reduce time between drug development and commercialisation, shortening lead times for an efficient supply chain
  • Do more with less in research and development (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

Kemwell’s Swedish facilities have more than 50 years of experience in supplying pharmaceutical products. The company’s core process technologies include wet and dry granulation, compaction, blending, and high shear mixing, as well as fluid bed drying, tablet pressing, capsule filling, semi-solid moulding, coating, and vision inspection.

Qualified person (QP) release services for pharmaceutical products

We also provide qualified person (QP) release services for Europe for products manufactured either at Kemwell’s site or outside the EU, covering the full chain of quality assurance (QA) responsibility for API and finished products. We have been inspected by the US FDA, EU, and Japanese regulatory authorities and supply to more than 80 markets worldwide.

Spread over 14,000m², Kemwell’s 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 building in Bangalore. It manufactures up to five billion tablets and capsules for global supply, covering more than 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. The compans ais building a new liquids facility to increase its manufacturing capacity.

Kemwell’s semi-solids facility has been in operation since 2001. The company manufactures 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 current good manufactruing practices (cGMP) 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

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Press Release

Cirrus Ready to Launch Clinical Trial Manufacturing at Raleigh-Durham Site

Cirrus Pharmaceuticals, a Kemwell company, has announced it is ready to launch its services for manufacturing cGMP materials for early phase clinical trials in its newly constructed state-of-the-art flexi-suite at its Raleigh-Durham, US site.

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Kemwell: Keeping You Competitive

Kemwell is a 100% customer oriented company with expertise in contract development and manufacturing services for pharmaceutical and biopharmaceutical products.

Address
Kemwell Biopharma Pvt. Ltd.

Kemwell House

11 Tumkur Road

Bangalore 560022

India

+91 80 3928 6200 +91 80 2337 9152 www.kemwellbiopharma.com

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Kemwell

Press Release

18 February 2016

Cirrus Pharmaceuticals, a Kemwell company, has announced it is ready to launch its services for manufacturing cGMP materials for early phase clinical trials in its newly constructed state-of-the-art flexi-suite at its Raleigh-Durham, US site.

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5 May 2015

Kemwell has been honoured with multiple awards at the CMO Leadership Awards.

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5 May 2015

Kemwell Biopharma has announced that its oral solids manufacturing facility located in Bangalore, India has successfully completed its second US Food and Drug Administration (FDA) inspection.

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19 November 2014

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.

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8 September 2014

Kemwell AB has announced that Mikael Ericson has been appointed as the new CEO of its operations in Sweden.

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31 August 2014

Kemwell has announced the appointment of Mikael Ericson as the new CEO of their Swedish operations.

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1 July 2014

Kemwell Biopharma has announced they successfully completed a current good manufacturing practice (cGMP) joint audit of its oral solids manufacturing facility in Bangalore, India.

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25 March 2014

Kemwell Biopharma, a global contract development and manufacturing services provider,
announced that it has installed and qualified its commercial-scale lyophilizer. With this expansion, Kemwell has added GMP lyophilization capability to its sterile injectable offerings for biologics and pharmaceuticals.

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2 March 2014

Biopharma has announced the appointment of Siddharth J Advant, PhD, as president of its biopharmaceutical services.

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17 October 2013

Cirrus Pharmaceuticals, a wholly owned subsidiary of Kemwell Biopharma Pvt, has announced that it has been awarded a grant by the US Food and Drug Administration entitled 'Comprehensive Evaluation of Formulation Effects on Metered Dose Inhaler Performance'.

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14 October 2013

Kemwell Biopharma, a leading global bio/pharmaceutical contract services company headquartered in Bangalore, India, has announced that it has acquired Cirrus Pharmaceuticals, a contract development services company based in Research Triangle Park, NC, US.

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30 November 2012

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.

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18 July 2012

Kemwell Biopharma has received approval from Health Canada to manufacture and supply oral solid dosage products from its facility in Bangalore to the Canadian market.

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4 July 2012

Kemwell Biopharma Pvt. Ltd., an India-based formulations contract manufacturer, 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.

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15 December 2010

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 large

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2 December 2010

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 ranging

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2 December 2010

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.

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28 November 2010

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 pro

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18 November 2010

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,

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3 June 2010

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 expa

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Regional Offices

Kemwell Biopharma Pvt. Ltd.

Kemwell House

11 Tumkur Road

Bangalore 560022

India

+91 80 3928 6200 +91 80 2337 9152 www.kemwellbiopharma.com
Kemwell AB

Visiting address: Rapsgatan 7

SE-751 82 Uppsala

Sweden

+ 46 18 16 40 00 + 46 18 16 40 45
Cirrus Pharmaceuticals

511 Davis Drive, Suite 100

Morrisville

NC 27560

North Carolina

United States of America

+1 919 884 2064 +1 919 884 2075 www.cirruspharm.com

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