Vetter Serializes First Product for South Korea

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-05-06-2015, Volume 11, Issue 5

CDMO Vetter produces identifiable labeling for a top-ten pharmaceutical company.

 

Vetter has announced that it has manufactured the first commercial batches with single-use identification numbers and implemented product serialization for secondary packaging in accordance with the requirements from the South Korean Ministry of Food and Drug Safety (MFDS). The Vetter solution identifies the drugs on the folding boxes via a 2-D data matrix code with a serial number, GTIN, expiry date, and batch number.

To combat counterfeit drugs, regulatory authorities worldwide are requiring clear identification of products through serialization; the smallest packaging unit must be marked with a single-use identification number. South Korea is among those countries requiring serialization with an aim towards protecting against counterfeiting, as well as a more secure supply chain.

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Presently, South Korea has only asked for serialization on the folding package. China has legislated use of 1-D linear codes including aggregation with the shipping box.

Vetter provides services in secondary packaging, primary packaging, and final assembly to accommodate various regulatory or market needs. The company's serialization service includes a range of formats for serial numbers, different code systems, interfaces, and reports, as well as various aggregation depths.

Source: Vetter