The pharmaceutical industry includes the manufacture, extraction, processing, purification, and packaging of chemical materials to be used as medications for humans or animals. Pharmaceutical manufacturing is divided into two major stages: the production of the active ingredient or drug (primary processing, or manufacture) and secondary processing, the conversion of the active drugs into products suitable for administration.
Formulation is also referred to as galenical production.
The main pharmaceutical groups manufactured include:
- Proprietary ethical products or prescription-only medicines (POM), which are usually patented products
- General ethical products, which are basically standard prescription-only medicines made to a recognized formula that may be specified in standard industry reference books
- Over-the counter (OTC), or nonprescription, products.
The products are available as tablets, capsules, liquids (in the form of solutions, suspensions, emulsions, gels, or injectables), creams (usually oil-in-water emulsions), ointments (usually water-in-oil emulsions), and aerosols, which contain inhalable products or products suitable for external use.
The major manufactured groups include:
- Antibiotics such as penicillin, streptomycin, tetracyclines, chloramphenicol, and anti-fungals
- Other synthetic drugs, including sulfa drugs, antituberculosis drugs, antileprotic drugs, analgesics, anesthetics, and antimalarials
- Synthetic hormones
- Glandular products
- Drugs of vegetable origin such as quinine, strychnine and brucine, emetine, and digitalis glycosides
- Vaccines and sera
- Other pharmaceutical chemicals such as calcium gluconate, ferrous salts, nikethamide, glycerophosphates, chloral hydrate, saccharin, antihistamines (including meclozine, and buclozine), tranquilizers (including meprobamate and chloropromoazine), antifilarials, diethyl carbamazine citrate, and oral anti-diabetics, including tolbutamide and chloropropamide
- Surgical sutures and dressings.
The principal manufacturing steps are:
- preparation of process intermediates;
- introduction of functional groups;
- coupling and esterification;
- separation processes such as washing and stripping;
- purification of the final product;
- tablet pressing,
- printing, and coating;
- filling; and
The manufacture of penicillin, for example, involves the batch fermentation—using 100–200 cubic meter (m3) batches—of maize steep liquor or a similar base, with organic precursors added to control the yield. Specific mold culture such as Penicillium chrysogenum for Type II is inoculated into the fermentation medium. Penicillin iseparated from the fermentation broth by solvent extraction. The product is further purified using acidic extraction. This is followed by treatment with a pyrogen-free distilled water solution containing the alkaline salt of the desired element. The purified aqueous concentrate is separated from the solvent in a supercentrifuge and pressurized through a biological filter to remove the final traces of bacteria and pyrogens. The solution can be concentrated by freeze drying or vacuum spray drying. Oil-soluble procaine penicillin is made by reacting a penicillin concentrate (20–30%) with a 50% aqueous solution of procaine hydrochloride. Procaine penicillin crystallizes from this mixture.