|Business Areas : Research|
|What is Chirality - in Dr. Mukund Gurjar’s words (Director, R & D)|
By the virtue of some specialized three dimentional structures, many organic compounds exist in two different forms which are mirror images. Although these two forms called isomers (referred as R & S isomers and racemic means a 50:50 mixture of R and S isomers) have same chemical properties, their biological activities differ significantly. This concept is called chirality. For instance, many drugs are racemic mixture of R and S isomers, in which only one isomer has correct therapeutic activity while the other isomer is either inert or has all together different bio-activity. There is no point offering drugs as racemic mixtures because only 50% activity is available. Therefore offering one isomer drug is always better, more effective and less side effects. It is our constant pursuit to develop chirally pure drugs which has led to the introduction of 8 such molecules already. What we have achieved is the removal of unwanted isomer from the drug and kept only the wanted or right isomer. For example, the 10 mg tablet of our new brand Dexpure is as effective as 20 mg of racemic rabeprazole. We are focusing our efforts on other critical therapeutic areas such as cardio-vascular diseases, Anaemia, nephrology, oncology, CNS, hormones & steroids and diabetes.
There are still over hundred racemic drugs in the market which are ideal candidates for chiral switches. We shall pursue them relentlessly.
Emcure, as the name indicates, is responsive to growing healthcare requirements. Therefore, research is at the heart of Emcure’s philosophy. Scientists, at Emcure believe that research is one of the best-and most rewarding-ways to go ahead. The robust R&D environment within the company for API, formulation as well as biotech products reflects the Company's commitment to be a global leader in the pharmaceutical field and has helped Emcure to be a one of the fastest growing organization.
Emcure, today has state-of-the-art, independent R & D facilities, in India, for API, formulation and biotech research. The Research Facility of Emcure is home to more than 300 skilled scientists, who are involved in innovative research for a wide range of therapeutic products. All our research facilities are approved by DSIR (Department of Scientific & Industrial Research), Ministry of Science & Technology, Government of India.
We are one of the pioneers in the field of Contract Research and work with academic institutions, governments, and other pharmaceutical and biotechnology companies. We believe that our combined efforts will help people live healthier and happier lives.
Emcure has to its credit about 90 patent applications, filed all over the world, protecting the in-house intellectual wealth generated at these R&D centres.
Emcure’s API research centre is one of the pioneers in the area of Chiral separation technology. Emcure is at the forefront of this technology. Emcure has a number of first to market to its credit in this niche area. Emcure R&D has successfully developed and commercialized various chiral molecules in the last couple of years. S-amlodipine, S-atenolol, S-pantoprazole, S-metoprolol, R-ondansetron are some of the notable examples from Emcure’s portfolio.
The focus areas of API research at Emcure are cardiovascular, haematinics and anti-retrovirals. For ARVs, our tie up with Bristol Myers Squibb for Atazanavir demonstrates our commitment in this direction. Emcure's research team is constantly working on synthesizing APIs in these therapeutic category using efficient, economical and environment friendly processes.
Emcure has tied up with multinational organizations for researching and commercializing a range of products. We believe that our combined efforts by way of such contract research will help people live healthier and happier lives.
The API R&D has about 65 patent applications and 7 US DMFs to its credit and offers an end-to-end solution for corporates as a Contract Research organization that can efficiently and effectively deliver a solution.
The API R&D infrastructure comprises process development laboratories, complete analytical equipment, microbiological facilities, kg scale facilities and pilot plant for scale up.
Additional facilities are being set up to work exclusively on oncology projects for the domestic / regulated markets.
Emcure has an ongoing association with two of India's pioneering research institutes, Indian Institutes of Technology and National Chemical Laboratory, Pune. Emcure's R&D team works closely with them on newer technologies.
Emcure's API team is skilled at:
- Design and synthesis of APIs and intermediates.
- Process optimization.
- Identification, isolation/synthesis of impurities and metabolites.
- Development and validation of analytical methodologies.
- Stability profiling.
- Degradation studies
- DMF creation and filing
Emcure has inherent strengths in formulation R&D and analytical chemistry. State-of-the-art facilities have been effective in creating high-quality formulations catering to the markets world over. Emcure has expertise in creating formulations of solids orals, injectables, liquids, creams and ointments.
Emcure has an integrated approach wherein formulation scientists work closely with the API development team to develop world class products. This is evident in the fact that Emcure has introduced over 150 formulations in the Indian market over the years.
The two formulation R&D facilities are spread over 30,000 sq. ft. of area and are equipped with various hi-tech equipments to develop sophisticated formulations.
Emcure has also successfully developed and commercialized a set of Novel Drug Delivery Systems (NDDS)such as
Foray in the regulated market:
- Instant Mouth Dissolve Technology for instant release of drug ideally suited for NSAIDS and antihistamines.
- Tablet in Tablet Technology for combination drugs one with an instant action form and a sustained action form.
- Chronotherapeutics tuned to the biological clock of the body for drug delivery at a desired time, such as the anti-asthmatic Theophylline.
- Colon specific drug delivery for targeted delivery of drug for ailments such as for amoebiasis using Tinidazole.
- Taste masking and chewable iron tablets with no metallic after -taste leading to better patient compliance.
- Abbreviated new drug applications for tablets and injectable dosage forms.
- Controlled release formulations for US market.
- Approvals under PEPFAR programme for anti-HIV drugs.
Emcure is carrying out research to creat e a range of life saving recombinant human biogenerics. Emcure has a world-class R&D facility with segregated areas for mammalian & yeast/bacterial cell based research as well as upstream and downstream processing facilities.
Emcure has a team of experienced research scientists and technologists with expertise in rH gene technology, process optimisation & downstream processing for bio-technology.
The current pipeline comprises products focusing on nephrology, oncology, cardiovascular and gynaecology. This range of bio-generics is already in various stages of the regulatory process in India.