Pharmaceutical raw materials are substances, chemicals, extracts, etc, which are the basis of manufacturing of pharmaceutical drugs.  While some of these substances are derived from natural sources as in the case of vegetable ingredients like Phytopharmaka, others are artificially manufactured through regulated chemical processes. Of late however, many of the raw materials derived from natural sources previously are being produced synthetically in part or even bio-technologically. This is so because manufacturing them artificially is economical, safer, and much quicker.

Other pharmaceutical raw materials are produced by genetic engineering viz. Insulin. Their manufacture entails processing with the help of bio-reactors where micro-organisms or mammalian cells are used. Still, other raw material agents are produced by chemical synthesis, and perhaps these are the ones most commonly used.

A varied range of products are produced using pharmaceutical raw materials. For instance, many skin care products such as sun protection cream, anti marks cream or hair care products such as anti-dandruff oil are manufactured using these.

Types of Pharmaceutical Raw Materials

There are several types of pharmaceuticals that are often classified based on their source.

Animal extract

Animal extracts are concentrated formulation prepared from animal material. The source of these substances may be varied and could include any biological material that serves as a good source of the material required. For example, source material may be cells grown in culture, plants, microorganism cultures, or tissues isolated from an animal organs like the lung, liver, muscle, brain, ovary, etc. Some examples of animal extracts include Beeswax, Chitin, Chitosan, Royal Jelly, Shark Cartilage

Drug Intermediate

A drug intermediate is any chemical substance that is produced at one stage during a synthetic process during drug manufacture and then utilized in the next stage. Some examples of drug intermediates include Acid Derivatives, Alcohol Derivatives, Amine Derivatives, Ester Derivatives, Phenone Derivatives, and Pyridine Derivatives. They may be use in making many different products such as medicated topical applications e.g. antibacterial soap.

Herbal Raw Materials

Herbal raw materials are natural pharmaceutical raw materials made from a plant or plants and for use in treatment of diseases and to promote health. Often, processes such as cooling, oil extraction, co2 extraction, distillation, pressing, etc are used to produce them. Herbal powders, psychoactive herbs, raw herbs, herb seeds, roots, leaves, fruits are some common herbal raw materials. Herbal raw material are widely used for manufacturing medicines and cosmetics such as shikakai shampoo and amla shampoo, or other skin care products viz. orange scrub, aloe vera gel, and more.

Pharmaceutical Additives

Pharmaceutical additives are inactive ingredients that comprise medicines. They are needed to color, flavor, bind, fill, lubricate, preserve and perform similar roles to make up a medicine. Some common examples of drug additives are sucrose, silicon dioxide, gelatin, cornstarch, magnesium stearate, lactose, calcium stearate, shellac, glaze and talc.

Buying Tips

It’s the quality of the ingredients which determines the quality of the product. The importance of the quality of Pharmaceutical raw materials can’t be overemphasized. The following tips would help you to procure quality pharmaceutical raw materials.

1. Establish the integrity of the source prior placing the order

2. Establish a list of approved suppliers.

3. Require that any alternative source of supply provides the following as a minimum:

a. A pedigree back to the previous source

b. Certification that it is not a diverted product

c. Certification that any actions by the alternative source will not alter any original manufacture warranties or guarantees

d. Certification that the product has been stored and handled consistent with product labeling requirements

4.Be wary if a product is being offered at an unusually cheap price.

5. Check for signs of a removed or switched product label

6. Check for subtle changes in the product’s package (compare with previously purchased products), notwithstanding legitimate parallel imported products

7. Look for variations in the size of the container (compare with previously purchased products), not withstanding legitimate parallel imported products

8. Look for differences in container length, diameters and shapes.

9. Examine for variations in diameters of bottle openings or lids.

10. Examine for variations in the thickness of glass or plastic containers and for variations in container color tints.

11. Compare the physical characteristics of the product

Industry Overview

The pharmaceutical raw material industry has a positive outlook for growth. Over the past couple of years the demand for generic drugs around the world has increased. Since the pharmaceutical raw material industry is highly dependent on the pharmaceutical and medical industry as a whole, hence much of its growth can be attributed to the growth of these industries.

In North America the climate is set for the industry to generate over US$ 21 billion in capital and maintenance projects scheduled to begin in 2008. Moreover, the growth of generics is forecasted to be three times as much as that of patented drugs pharmaceuticals, thus requiring and equivalent amount of drug raw materials.

In Europe too, the pharmaceutical markets have grown at a fast rate. While the total pharmaceutical market value in 1990 was US$ 173,000 million, it grew to reach US$ 466,300 million. Some of the top pharmaceutical markets in Europe are Germany, France, UK, Italy and Spain.