Saudi Arabia serialization rules prompt Recipharm investment; US plant open

By Gareth Macdonald contact

- Last updated on GMT

iStock/Golden_Brown
iStock/Golden_Brown

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Drug track and trace rules introduced in Saudi Arabia prompted a €300,000 ($326,078) investment in processing technology and software according to Sweden-based contractor Recipharm.

On Monday, Recipharm announced it had shipped several batches of drugs to Saudi Arabia, explaining the products were labelled in accordance with serialization rules introduced in November​ in the latest version of the Saudi Drug Code.

In order to comply with the new rules – which came into effect last month – Recipharm had to install technology at its manufacturing site in Lisbon, Portugal.

Marchesini and SEA Vision provided the hardware and software according to Staffan Widengren, director corporate projects at Recipharm, who told us the investment fitted with the firm’s wider €40m serialization capacity effort.

“This project at our site in Lisbon is part of Recipharm's global serialisation program and  it requires steering from central stakeholders as well as support from vendors of equipment, hardware and software.”

Widengren added that: “From the local site it is important to engage all functions that are involved in the process of packaging including serialisation, release and distribution of batches independent of markets.”

Saudi serialization 

Like other serialization requirements elsewhere, the Saudi rules are designed to prevent counterfeit products entering the supply chain.

Drug companies are required to replace linear barcodes with GS1 DataMatrix barcodes, which include a unique product identifier, batch number, expiry date and serial number.

Clinical manufacturing expansion

In other news, Recipharm opened a manufacturing suite for clinical trial materials at its facility in Research Triangle Park, North Carolina, US.

The facility, which cost $750,000, is designed to supply non-sterile dosage forms, semi-solid topical drugs and products in metered dose inhalers for customers running Phase II trials.

Related topics: Regulatory & Safety, Regulations

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