Normon Laboratories selects TraceLink to comply with EU FMD
TraceLink selected for its demonstrated EU and country compliance capabilities and enterprise scalability.
Spanish-based pharmaceutical manufacturer, Normon Laboratories, has selected TraceLink's serialization solutions to comply with the EU Falsified Medicines Directive (FMD) requirements.
The first generics pharmaceutical manufacturer in Spain, Normon Laboratories, has grown to be a global player, supplying products to multiple markets. With high volumes of pharmaceuticals shipped throughout Spain and exported across the rest of the world, and offering additional contract manufacturing capabilities for customers, the company needed a serialization solution that could accommodate its various roles in the pharmaceutical supply chain and ensure compliance for its customers, as well as its own product lines. Normon selected TraceLink for its ability to scale at the enterprise level and its seamless integration with multiple contract manufacturing organizations, to enable compliance with the EU FMD serialization regulations.
“At Normon, we uphold our commitment to developing the safest and highest quality medicines at affordable prices for everyone. Our dedication to ensuring patient safety was a key factor in selecting a partner with a proven solution to comply with the EU FMD,” said Gonzalo Fernández Govantes, Chief Operating Officer of Normon Laboratories. “We selected TraceLink for its demonstrated EU and country compliance capabilities and enterprise scalability. As Normon continues to expand its business through ongoing innovation, we are confident that TraceLink can provide the breadth of support needed in order for Normon to successfully comply with EU and global regulations."
“We are pleased to be working with Normon Laboratories, a pioneer in the development of generic medications, and one of the leading pharmaceutical companies in Spain. At TraceLink, we understand and value the need to implement an EU FMD compliance strategy that can scale quickly to accommodate for rapid growth and impending deadlines for serialization and individual country compliance,” said Shabbir Dahod, president and CEO of TraceLink. “Drug traceability and serialization is a global initiative and we look forward to working closely with Normon Laboratories to meet the approaching EU FMD deadline for serialization and ultimately, help secure the integrity of its products for patients across Europe.”
Related News
-
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Pharma Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain. -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News BIOSECURE Act continues to loom over Chinese pharma manufacturers
With the US BIOSECURE Act on its way to passing into legislation, Chinese companies are facing declining revenues within the first half of 2024 as US pharmaceutical and healthcare companies pull their businesses from the country. -
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance