Interruption of production at Swiss contract manufacturer may temporarily disrupt supplies

12.10.2020

During an inspection, Swissmedic found a number of GMP deficiencies in the production area. The company concerned has had to suspend production of sterile medicinal products until the necessary corrective actions have been completed. As a result, the supply of some of the medicinal products concerned – which are used primarily in hospitals – may be temporarily disrupted.

During an inspection at the end of August 2020, Swissmedic discovered a number of production deficiencies at Legacy Pharmaceuticals Switzerland GmbH, a Swiss contract manufacturer of pharmaceutical products. Swissmedic immediately instituted administrative proceedings to have the company’s manufacturing licence partially suspended and obliged the company to draw up and implement a corrective and preventive action plan (“CAPA”).

Until a follow-up inspection has confirmed that the quality, maintenance and qualification of the plant in question meets GMP requirements, the production and sale of various sterile products have been temporarily halted.

The authorisation holders for the medicinal products concerned have been informed accordingly. Swissmedic has also informed its partner authorities of this matter, as a number of the products are exported.

Possible interruption to supplies

Since production has been halted for the time being, supplies of certain medicinal products that are used mainly in hospitals may be interrupted for an unspecified period. Swissmedic is currently investigating whether individual batches of products on the Swiss market will have to be recalled. In the case of products that are critical in terms of therapeutic applications and/or availability of alternatives, Swissmedic is currently examining whether individual batches – or some of the batches that have already been manufactured – may be released.

In doing so, Swissmedic is bearing in mind that the supply situation for certain medicinal products manufactured by this company may be critical, as well as considering patient safety. Swissmedic will provide information on further developments as soon as it is available.

The following may be affected by temporary supply shortages:
Authorisation no.	Preparation	Use
15160	Protamin® Ipex, solution for injection	Inactivation/neutralisation of heparin
40467	Ancotil®, solution for infusion 1% (i.v.)	Treatment of mycoses (fungal infections)

As at 20 november 2020; subject to change. The list given below of products that could be affected by temporary interruptions to deliveries has been updated. At present it does not look as though Liquemin 25000 I.U., solution for injection (authorisation no. 15159) will be affected by supply bottlenecks.

Further links

EudraGMDP database, non-compliance statement

Report no. CH20-0566