Even among clients outside the US, approval by the US Food and Drug Administration (FDA) is an important endorsement, according to ChemCon, a German company which develops and manufactures custom active pharmaceutical ingredients (APIs) as well as performing contract R&D.
FDA inspections are “relevant for an awful lot of our customers because they represent one of the best signs of quality,” Owen Pryce, Sales Manager, ChemCon, told in-PharmaTechnologist.com.
According to a budget request for the new fiscal year, FDA inspections outside the USA are planned to increase at a far greater rate than domestically, numbering 999 in 2015.
Fourth inspection
ChemCon passed an FDA inspection of its main site in Freiburg, Germany, it announced this week. The review of GMP compliance examined quality assurance systems relating to the production of APIs for a US market, said Pryce.
Such visits include checks on equipment, manufacturing facilities, materials and quality controls and can result in the FDA issuing a Form 483 to failing sites.
In ChemCon’s case, an “NAI” (no action indicated) classification was given to the plant, which has four clean rooms. This is its fourth FDA inspection since it was built 17 years ago.
Custom API supply
ChemCon’s API customers are mostly European and North American, with other markets in the Middle East, Australia and Japan, Pryce told us.
The company specialises in small molecule organic and inorganic chemistry, creating custom APIs.
“If a customer wants a completely new API that’s not on the market, we can develop that and then we can upscale under GMP conditions,” said Pryce. The firm also supplies generic APIs already on the market.
Tobias Timtner, ChemCon spokesman, described the company's production of ingredients for commercial purposes, including highly potent APIs, as “small to medium scale,” from a few hundred grams up to several hundred kg per year, depending on the type of API.
ChemCon was approved last December to manufacture semisolid dosage forms.