Serialization first in South Korea

Contract development and manufacturing organization delivers identifiable labeling for a top-10 pharmaceutical company.

Following the introduction of a comprehensive serialization service last year, Vetter announces the manufacture of commercial batches with single-use identification numbers.

The company says it has now implemented product serialization for secondary packaging for one of the world's leading pharmaceutical companies. In accordance with the requirements from the South Korean Ministry of Food and Drug Safety (MFDS) Vetter's serialization services identify the drugs on folding boxes via a 2-D datamatrix code with a serial number, GTIN, expiry date, and batch number.

As the number of counterfeit drugs continues to grow, regulatory authorities around the world are increasingly relying on clear identification of products through serialization. They are demanding that the smallest packaging unit be marked with a single-use identification number. South Korea is among those countries requiring serialization with an aim toward protecting against counterfeiting, as well as a more secure supply chain.

"Together with our customer, we prepared for these requirements very early on," says Thomas Otto, Managing Director at Vetter. "We have been active in filling and final packaging for the company for years. Our partner can now meet the regulatory requirements for South Korea.”

Presently, South Korea has only asked for serialization on the folding package. China, however, has legislated use of 1-D linear codes including aggregation with the shipping box. As such, Vetter provides primary and secondary packaging, as well as final assembly. The company's serialization service includes a range of formats for serial numbers, and different code systems such as a 2-D datamatrix codes, interfaces and reports, as well as various aggregation depths. Pharmaceutical and biotech companies can use Vetter's individually customizable solutions as basis for their own track-and-trace programs to optimize their supply chain.

Vetter is a contract development and manufacturing organization (CDMO) and works in the fill and finish of aseptically prefilled syringe systems, cartridges and vials. Headquartered in Ravensburg, Germany, the company runs facilities in Germany and the U.S.

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