A generic drug is identical to an innovative drug and contains the identical active pharmaceutical ingredient. In order to be approved by the regulators, generic drugs have to meet the same strict standards as the innovative drugs. Generic drugs contain the same active ingredients and they are bioequivalent to the innovative drugs. Furthermore, they have to be identical in strength and dosage form, have the same use indications and to be manufactured under the strict GMP regulations. These regulations contain the same batch requirements for identity, strength, purity and quality required for innovator products.
- Why are generic drugs important?
High price of the innovative drug: The scientific research, development and many pre-clinical and clinical studies for a new drug development account for the high price of the innovator drug. Innovator pharmaceutical companies patent their new drugs, having exclusive right to sell their product at high prices. Generics only become available after the patent expiration, which may last up to 20 years.
Lower price of the generics: Generic companies do not have the burden of such expensive research and development costs which leads to more acceptable prices for the patients and health and insurance funds. In addition, the competition provides perfect settings for high quality at very competitive and affordable prices. Under these conditions, billions are saved with the use of generic drugs every year.
- Alkaloid generics – added value
The production of affordable, high quality pharmaceutical products and a wide range of consumer goods are at the core of our company values.
We manufacture effective and safe drugs by applying Good Manufacturing Practice principles (GMP), providing a robust portfolio of high quality products. We comply with the standards, guidelines and directives, both as a legal obligation and commitment to quality, safety and efficacy of all our products.
Our manufacturing capacities extent both spectrum of Rx and OTC products.
Added value of our high quality generic products is the constant quality monitoring and providing compliance with the requirements posed on behalf of EU and US regulatory authorities, by our new and highly developed Institute(s) for Research and Development and the Centre for Quality Control. Our primary care and work is focused towards providing high quality product that will completely meet the needs of the patients, leading to our objective – providing healthier life for each individual-as we believe in HEALTH ABOVE ALL.