Profiles in Biotechnology, Standards, Machinery, Innovation, Global Know-how, Strategies, and Expansion - Pharmaceutical Technology

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Profiles in Biotechnology, Standards, Machinery, Innovation, Global Know-how, Strategies, and Expansion


Pharmaceutical Technology



Made-in-India Excellence: Dabur
Although Cadila's profile is largely in generics, it is investing heavily in R&D to develop a hybrid profile and to bring new chemical entities to the market, in particular in the field of adjuvants. The company is also working on drug-delivery systems. Recognizing the dual nature of his organization, Khamar adds, "We support the large generic companies as far as APIs are concerned and work in partnership with them, but today we also have a platform to work with the innovating companies on a partnership model. "

Cadila is representative of various players that may soon bring additional value to the industry, both locally and globally. Modi, who has been at the forefront of the sector as president of the Indian Drug Manufacturers' Association (IDMA) and chairman of the Basic Chemicals, Pharmaceuticals, and Cosmetics Export Promotion Council (CHEMEXCIL), has been credited many times over for his belief in the strength of the public-private partnership and the positive impact of the 1970 Indian Patents Act on the industry. Today, he aims to provide a clear international approach to his organization and is proud to point out his company's five abbreviated new drug applications with the US Food and Drug Administration. The applications will be followed by two to three more this year, and as many as six in 2008.

Meanwhile, on the API front, Cadila, under the leadership of Rajiv Varma, president of the company's API business, has 15 drug master files and will be submitting 10 to 12 per year going forward. It seems clear, therefore, that Cadila's dynamism isn't about to wane—rather, Cadila is a company to watch.

Serving the World

Profile: Dishman Pharmaceuticals and Chemicals Limited


J.R. Vyas
Contract research and manufacturing services (CRAMS) is a favored model among many Indian pharmaceutical companies. Some have added these activities to their core business alongside development, realizing its potential for outsourcing to the West. Others established their companies with CRAMS from the onset. Take Dishman Pharmaceuticals and Chemicals Limited (Ahmedabad), one of India's largest companies. Since its establishment in 1989, the company's managing director, J.R. Vyas, has taken a unique approach compared with other local manufacturers. "Most of the companies here went after generic APIs [active pharmaceutical ingredients], then generic formulations," he explains. "The awareness for CRAMS has risen later, in particular for mid-sized companies. But opportunities lay for this size of companies: The model will become stronger and stronger in the years to come as Big Pharma companies who can also do it have already put their priorities somewhere else, like in formulations, creating their own field forces in Europe and the US and geting better value from their formulated products."

With a strong base in specialty chemicals and a solid research and development backbone established following a $100 million investment, Dishman can help formulators develop compounds on scales from grams to tons. But the unusual aspect of the company's model is its strong noncompetitive dimension—the company is not a generic player. "We are a pioneer in the CRAMS profile and have to create our own structured models," explains Vyas. "We are not into generic APIs although we are producing intermediates and have the capabilities to develop generic products when required. So we have a technology-transfer division where we develop technologies for our customers, license them for a small fee, but offer to our clients the possibility to enter a supply agreement for the intermediates. This is both an innovative and contract manufacturing agreement model."


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
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