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biotech company or a pharmaceutical company researches, develops and distribute drugs and medicines. The biotech companies have to undergo a variety of laws and regulations in order to test, market and patent a particular drug.
The biotech industry is directly related to the discoveries and inventions made in the world. Every single development in the medical and health care industry leaves an impression on the biotech companies. Generally the large and multinational biotech companies patronize large scale drug discovery and developments along with manufacturing and doing quality control and marketing. The smaller biotech companies on the other hand participate in developing formulations and discovering drug candidates. Sometimes both the big scale and small scale biotech companies join hand for a particular project.
The drug discovery includes discovering the potential drugs by using the modern biotechnology techniques.
Biotechnology generally stresses on understanding the metabolic pathways that is related to a disease and thus manipulates these pathways in order to gain a perfect solution.When the suitability of a compound is established, the next stage in the process is the drug development by the biotech companies.In a country like the USA, all the new biotech products better known as pharmaceutical products must be approved by the FDA.
The process of getting a certification from FDA involves the
biotech company to submit the new drug and file for Investigational New Drug (IND) with available pre-clinical data and then proceed with human trials. After the IND certifies, three phases of human clinical trials are conducted. The first phase studies the toxicity of the medicine using healthy human volunteer, phase 2 includes dosing in patients and the third phase is a large study of the efficacy in the patient population. To minimize the chances of causing any harmful side effects, the FDA conducts a fourth phase of testing known as post-approval observation. After showing the green light to a particular drug or medicine, the FDA publishes the entire information about the drug in Orange Book site.
As the biotech products directly affects the health of the people, the biotech companies have to follow certain regulations and rules in order to get a license for doing business. Whenever any pharmaceutical products showed adverse side effects, the concerned companies have been caught in the law suit.
Some of the major biotech companies of the world are:
- Pfizer (USA)
- GlaxoSmithKline (UK)
- Novartis (Switzerland)
- Sanofi-Aventis (France)
- Johnson & Johnson (USA)
- Wyeth (USA)
- Merck & Co. (USA)
- Bayer (Germany)
- Baxter International (USA)
- AstraZeneca (UK-Sweden)
- Dr. Reddy’s Laboratories Ltd (India)