Development

Cadila’s research capabilities covers all phases of pharmaceutical development: From preclinical research to large scale pivotal clinical studies. With facilities and quality management procedures setup to comply with international standards, Cadila has a proven track record of developing both generic and new products from early stage to domestic and international markets. Innovative products like ‘Polycap’ for cardiovascular disease, Risorine for tuberculosis and Mycidac-C for lung cancer have all been developed in-house by Cadila.

The Cadila R&D facilities are spread over more than 9,500 square meters and employs more than 300 scientists.

The development capabilities of Cadila also includes considerable experience in formulation development, both for proprietary products and generics. The portfolio of formulations contains over 850 products in various forms covering all important therapeutic segments. Technological capabilities cover small molecules, vaccines and biologics (see www.cplbio.com).

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Generic outline of activities during drug development.

F&D Formulation Development

Cadila encompasses a highly experienced team in preformulation and pharmaceutical development.  The team covers expertise in analytical research, technology transfer, stability studies and packaging development. Dosage forms include oral, topical, and injectables.

Cadila’s formulation capabilities cover all phases of the pharmaceutical value chain, from preparation of preclinical study material, through clinical trial supply to commercial manufacture of final products.

Preclinical development

Cadila conducts preclinical testing to support pharmaceutical development both in Europe, US and India.

In the preclinical development phase, we assess the risk of drug candidates to human health prior to, during and after clinical development. Non-clinical testing is conducted throughout all phases of drug development in order to assess the pharmacodynamic, ADME and pharmacokinetic and toxicokinetic (PK/TK) characteristics and safety profile. Typically, both in vitro and in vivo tests are performed.

During preclinical development, many studies need to follow general regulatory ICH guidelines (GLP) to be acceptable for submission to global regulatory agencies or allowing the drug to be taken into the next clinical phase, or to product registration.

The preclinical experts at Cadila have a broad experience and hands-on drug development expertise with respect to design, monitoring for PK/TK, ADME, safety pharmacology and toxicology studies and are either conducted at Cadila´s facilities or subcontracted to specialized contract research organisations (CROs).

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Preclinical facility

The research organization is housed in a brand new pre-clinical facility in Dholka, Gujarat, and offers comprehensive solutions for integrated drug development. The facility offers all necessary aspects of non-clinical safety and efficacy evaluations of a broad range of pharmaceuticals, including vaccines.

All units of the facility are run in accordance with GLP (Good Laboratory Practice) standards in order to deliver high quality research.

The facility houses key functional areas such as animal breeding unit, clinical pathology, histopathology, microbiology, blood collection and post-mortem.

Clinical development

Cadila conducts clinical trials of all phases (I-IV) in several therapeutic areas such as oncology, cardiovascular, and anti-infectives. Clinical trials are conducted according to ICH Good Clinical Practice guidelines and complies with EMA and US-FDA requirements.

With an extensive network of hospitals and medical institutes throughout India and a large database of investigators, cost effective clinical trials are delivered according to global regulatory requirements. More information about our ongoing trials in India (both local and international) can be found on http://ctri.nic.in/Clinicaltrials/login.php . Cadila has in-house personnel to cover all activities associated with setup and management of clinical studies, from protocol development , data management and biostatistics, study site management, report writing and regulatory.

Cadila Pharmaceuticals is the first Indian company to get Investigational New Drug (IND) approval by USFDA for clinical trials to be conducted in India. The company has five IND dossiers filed with the USFDA for pulmonary tubercolusis, lung cancer, prostate cancer, bladder cancer and melanoma. 20 ANDAs have been submitted. As of December 2016, Cadila had six ANDAs approved by US-FDA, four Marketing approvals in UK and seven products approved in Australia and New Zealand.

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In-house phase I unit

The unit consists of 66 beds with two Intensive Care Units. There are separate areas for sample processing and storage. We also have a fully equipped bioanalytical lab with more than 90 validated bioanalytical methods. Our unit have passed inspections by US-FDA and European Health Authorities (CMDh). We run approximately 30 Bioequivalent/Bioavailability studies annually and have a datapool with about 6000 Healthy Volunteers. The studies mainly support Abbreviated New Drug Applications (ANDAs) and we submit applications to both US-FDA, Europe and other parts of the world.

First time in man studies are conducted at a specialized unit at the Apollo hospital in Ahmedabad (www.apolloahd.com).

Marketing

Cadila Pharmaceuticals has over 400 brands spanning over 33 therapeutic categories. The domestic marketing network contains a 4,000 field force with a coverage of over 250,000 doctors across India.

International presence

Internationally, Cadila Pharmaceuticals has operations in more than 100 countries with over 1,200 marketing authorizations in total and a sales force of over 300. Products are also marketed through a network of 65 distributors worldwide.

Manufacturing

The manufacturing facilities of Cadila Pharmaceuticals conform with the international cGMP norms  WHO-GMP, WHO-Geneva, USFDA, TGA Australia, MHRA UK, MCC South Africa, and ISO 9001/ISO 14001.

More than 50 Active Pharmaceutical Ingredients (API) are manufactured by Cadila, with many of these having a Drug Master File registered in the EU and US. The API manufacturing plant, based in Ankleshwar, is accredited by USF DA and European Directorate of Quality Medicine, among others.

The company’s primary product manufacturing plant in Dholka near Ahmedabad, Gujarat is USFDA approved and has a certificate of GMP compliance issued by MHRA UK. An additional manufacturing facility is located at Samba in Jammu and Kashmir. This facility fulfils international quality standards to produce tablets, capsules, soft and hard gelatin capsules and liquids.

Cadila has also a manufacturing facility in Addis Ababa, Ethiopia, which is the only WHO-cGMP compliant manufacturing facility in the region.

In total, the company portfolio consists of over 800 products, of which 200 are offered internationally.

Services

We offer manufacturing and development services at any stage. Please contact us to find out how Cadila Pharmaceuticals Sweden can assist you.

Development services

Our organization offers pre-clinical and clinical studies for drug development compliant to the standards of all major markets, including Europe and US.

Services covers all phases of pre-clinical and clinical development, including:

  • GLP toxicology studies
  • Protocol development and medical writing
  • Conduct of clinical studies
  • Data analysis and reporting
  • Regulatory
Fixed price IND package

Cadila Sweden is able to offer a complete pre-clinical development program at a fixed price to make your candidate drug ready for first-in human clinical trial application in Europe.

The development program includes:

  • CMC Activities
    • Physico-chemical properties analysis
    • Formulation development
    • Analytical development
    • Manufacturing of drug product, including release for study in EU
  • Preclinical studies:
    • ADME
    • Gentoxicity studies
    • Toxicology studies
    • Safety pharmacology core battery

For further details of the program, download the Fixed IND package flyer

Manufacturing services

The contract manufacturing services are carried out at state-of-the-art facilities adhering to GMP. The services cover a broad range of APIs and drug products.

Cadila’s manufacturing capabilities ranges from small-scale production for clinical trials to large scale commercial supply. Cadila Pharmaceuticals Sweden has successfully managed manufacturing and regulatory submission of drug products for clinical trial application in Europe.