Manufacturing of Active Pharmaceutical Ingredients
Production of ingredients for drugs has become increasingly multifaceted and tougher to enable the handling of more deadly diseases and viruses.
API manufacturing in particular are more potent today than they were ten years ago.
This increase in deadly diseases and viruses has led to a good number of API manufacturers improve the effectiveness and quality assurance of these ingredients and safeguarding the wellbeing of their employees who handle them at the same time.
API manufacturing companies use certain standards to determine how powerful the API is on each drug.
The rules can be different from one brand to another. Each brand might use different tests to check their efficiency. Different manufacturers use different standardizing tests
The regularization of scrutiny is also a challenge. Different medical bodies in different countries have different regulation standards, some check on facilities, others, documentation while still others check on packaging. There has not been a general standard or guideline for a final regulation of inspections. This disparity needs to be standardized.
A recent study by a business research and consultancy firm Frost and Sullivan on the dynamic changes of the global API market, notes that there have been numerous examples of nonconformity of API manufacturing with the stated quality criteria, leading to a global negative opinion on companies in Asian countries.
“Bulk Pharmaceuticals”, as API manufacturing are commonly referred to, are usually made in places far from where the final medications (tablets, suspensions, and liquids) are produced. Due to the expensive nature of putting infrastructure in place in the developed countries, outsourcing became the cheaper option. Asia is having the greatest concentration of API manufacturers specifically in India and China. This leads to cheaper drugs especially to the developing countries.
APIs are produced through various methods that include:
- Chemical synthesis
- Fermentation process
- Recombinant DNA or other biotechnology methods
- Isolation/recovery from natural sources
- or any recipe of the above processes