Contract Manufacturing Regulatory Approval Round-Up

By Dan Stanton

- Last updated on GMT

Related tags Good manufacturing practice Regulation

Contract Manufacturing Regulatory Approval Round-Up
Evonik gets the thumbs up from the MHRA, Recipharm's approved by Japan and Simcere passes the Chinese regulatory test – welcome to Outsourcing-Pharma’s round-up of GMP accreditation.

Good manufacturing practice (GMP) provides assurances of quality and safety for manufacturers and for a CMO (contract manufacturing organization) accreditation can lead the way to new markets and new clients. This week scans the globe and brings news of regulatory approvals with a real international flavor.

First up is the news that Evonik​ has received current GMP certification from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA​), on behalf of the European Medicine’s Agency (EMA​), at its Birmingham, Alabama facility.

With this approval, the Evonik Birmingham Laboratories site will manufacture the drug Scenesse - a proprietary, photoprotective orphan drug for the disease erythropoietic protoporphyria – on behalf of client Clinuvel who has submitted a marketing authorisation application to the EMA for the drug.

“The certification provides our clients with additional assurance regarding the readiness of this facility to meet the highest quality and regulatory standards,”​ said Dr. Jean-Luc Herbeaux, head of the Health Care Business Line of Evonik. “We look forward to further growth in the area of manufacturing of complex dosage forms.”

This week also saw an extension of Franco-Japanese relations, at least with regards to the supply of Recipharm​ manufactured products to Japan. A recent inspection by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA​) at Recipharm’s solid dose facility in Fontaine, France has led to approval for the Swedish CDMO (contract development and manufacturing organization) to access and expand in the Japanese market.

General Manager at the Fontaine site, Stéphane Guisado, said: “Supplying products to Japan involves carrying out a substantial number of additional activities and meeting stringent requirements for enhanced quality control and we have met these challenges head on.”

Guisado also said Fontaine – which is already EU and US accredited - drew upon the experience of other Recipharm sites which are already supplying Japan.

And from Japan, let us jump over North Korea and enter China with news that the State Food and Drug Administration (SFDA​) has issued cGMP to Simcere Vaxtec​ – a manufacturing subsidiary of Chinese company Simcere Pharmaceutical Group.

The facility in Jiangsu will now recommence the production of an influenza vaccine.

Simcere could not give much more information to at present but Chief Science Officer, Dr. Peng Wang, did say: “We can only be certain that the SFDA's approval has further proven our capability of manufacturing quality products.”

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