Kemwell Pharmaceutical Contract Development, Manufacturing, Packaging and Distribution

CDMO services for the pharmaceutical industry

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.

About Kemwell

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.

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Press Release

Kemwell to Exhibit at BioPharma India Convention 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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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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Press Release

18 February 2016

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.

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5 May 2015

Kemwell has won multiple awards at the CMO Leadership Awards.

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5 May 2015

Kemwell Biopharma has announced that its oral solids manufacturing facility 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, 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.

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31 August 2014

Mikael Ericson will be the new CEO of Kemwell's Swedish operations.

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1 July 2014

Kemwell Biopharma has 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 has announced it has installed and qualified its commercial-scale lyophilizer.

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2 March 2014

Siddharth J Advant, PhD, is the new president of its biopharmaceutical services.

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17 October 2013

Cirrus Pharmaceuticals has been awarded a grant by the US Food and Drug Administration for evaluating formulation effects on MDI performance.

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14 October 2013

Bangalore-based Kemwell Biopharma has announced the acquisition of US-based Cirrus Pharmaceuticals, which specialises in contract development services.

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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'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.

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4 July 2012

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.

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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

+1 919 397 3000 +1 919 884 2075 www.cirruspharm.com

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