Why aren’t more manufacturers producing penicillin?
- 17, 09, 2019
Three of the four companies that still produce the active pharmaceutical ingredient for benzathine penicillin G are located in China. These are North China Pharmaceutical Group Semisyntech Co. Ltd, CSPC Pharmaceuticals Group Ltd., and Jiangxi Dongfeng Pharmaceutical Co. The fourth company is Austria-based Sandoz GmbH.
These companies produce only 20 percent of what they could because benzathine penicillin G is “off-patent, offers little profit and because demand data is extremely limited,” according to the WHO. The medicine’s cheap selling price also makes manufacturers disinclined to enter the market.
With so few producers, drugmakers say they do not have many options when it comes to sourcing the drug’s ingredients.
Two years ago, while Portugal was struggling with a shortage of benzathine penicillin G, Portuguese drugmaker Laboratorios Atral SA turned to China after its former European supplier changed the presentation of the active substance – which Atral says made it incompatible with its formulation process.
Atral says none of the companies they evaluated in China had the full set of documents demanded by the European Union, such as a certificate of suitability or the Active Substance Master File (ASMF), where a producer details its manufacturing process.
But, with no other options, the European drugmaker assisted the manufacturer in bringing together a package of information in line with EU legislation. Atral says it has audited the Chinese manufacturer, whose name it hasn’t disclosed, to ensure their standards.
“It is not easy. There are a few producers and, of those that are in the market, one is banned and the others don’t have complete documentation,” says Eduardo Oliveira, regulatory affairs director of Atral.
The company’s penicillin brand Lentocilli S is sold to at least five other countries.
South Africa last year also sourced more than 242,000 vials of unregistered benzathine penicillin G from North China Pharmaceutical Group Corp (NCPC), the parenting company of Semisyntech, through an emergency scheme.
Even India, a leading pharmaceutical producer, outsources almost all production of penicillin G to China, according to the Indian Drug Manufacturers’ Association (IDMA). “India became unviable as China’s price is too low to compete with,” says Ashok Kumar Madan, executive director of IDMA.
Global reliance on a few manufacturers can compromise the stability of supply as manufacturing delays or failure in one of these sites can affect several countries and millions of patients at once. Shortages mean sick people are sometimes treated with less efficient and more expensive drugs. According to a 2015 survey with European hospital pharmacists, half said patients were given inferior drugs during shortages. More than a third said stock outs led to medication errors.
And stock-outs are not rare. “Hospital pharmacists in Europe will usually face difficulties in sourcing a medicine that is not immediately available in their country,” notes Steve Glass, chief commercial officer of Clinigen for North America and Europe, a company that supplies hospitals with medicines.
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