The term ‘Pharmaceutical formulations manufacturer’ is often mixed up with the term, ‘bulk drugs manufacturer’. Though they indicate more or less the same thing that is provider of medicines there is a thin line of distinction between the two and it is necessary to get the basics right. Understanding the Basics Bulk drug or active pharmaceutical ingredient (API) as it is also known is the chemical molecule contained in the medicine that is bought from the chemist and it is this substance that gives the medicine its therapeutic effect. Besides the API, there are certain other ingredients that are included in the medicines and these are the inactive ingredients or excipients as they are called. These can vary from product to product but the bulk drug or API remains the same for the particular medicine as that is the identity of the medicine. Manufacturers of Bulk Drugs Formulations APIs or bulk drugs are manufactured in plants which could be far from the units where capsules, topical applications or oral suspensions are made. Almost all APIs are produced in the form of powders. The chemical plants established in each country manufacturer bulk drugs and their working is regulated to meet the standards of quality and safety laid down by the drug regulator of that country. The Indian Pharmaceutical industry which includes the manufacturers of bulk drugs and the formulations has seen a phenomenal growth in recent years. This is attributed to an increasing demand for cost-effective drugs in the domestic as well as export market. The Indian Pharmaceutical industry has become a strong contender in the international markets due to adoption of Good Manufacturing Practices (GMP) and also WHO GMP norms as decided by the World Health Organization for production of several dosage forms. Bulk drugs falling into main therapeutic groups which require complex manufacturing processes are produced in India today.
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