Renata earns EU GMP certification, eyes expansion in global markets

Renata PLC, one of Bangladesh's leading pharmaceutical companies, has received the European Union good manufacturing practice (EU GMP) certification for its Rajendrapur General Facility, marking a key milestone in its journey to strengthen its global footprint.

The drug maker, in a disclosure today (16 July), said it earned the certification following a comprehensive audit by European authorities, which cements Renata's position as a pioneer in pharmaceutical manufacturing excellence based in South Asia.

Good manufacturing practice (GMP) refers to the minimum standards that manufacturers must adhere to in their production processes to ensure the quality and safety of medicines. 

The European Medicines Agency (EMA) oversees the implementation of these standards across EU member states. All pharmaceutical manufacturers aiming to supply medicines to the EU market must comply with these rules, regardless of where they are based. 

Renata said its Rajendrapur General Facility is equipped with state-of-the-art production lines capable of manufacturing pharmaceutical products of oral solid dosage form, such as capsules, tablets, and soft gel capsules. 

This diverse manufacturing capability enables Renata to effectively serve both domestic and international markets, highlighting the facility's advanced technical and operational standards, it said. 

"With the certification, a new door has opened to the global market," said Jubayer Alam, company secretary of Renata PLC. "This is crucial for exporting medicines to European countries and will help Renata strengthen its global footprint."

"Now, we can easily export our products to EU countries, which will boost Renata's exports to Europe," he added.
Moreover, several Latin American countries also recognise the EU GMP certification, opening further opportunities for expansion, he noted.

Along with its subsidiaries in the United Kingdom and in Ireland, Renata is now exporting to 50 countries across the world. 

It manufactures a wide range of pharmaceutical products, including antibiotics, anti-inflammatories, analgesics, vitamins, neurological products, anti-diabetics, anti-cancer products etc. 

Besides, it is a market leader in Animal Health Products and has a focus on its Agro-based and Consumer Products. 

In FY2023–24, Renata exported medicines worth Tk191 crore, up from Tk183.28 crore in the previous fiscal year.

According to its annual report, Renata posted total revenue of Tk3,771 crore in FY24, a 14.4% increase from Tk3,297 crore in FY23.
The pharmaceutical business alone registered a 12.2% year-on-year growth, while including other segments, overall growth reached 16.6%. The Animal Health division remained a strong performer with 9.1% growth, and agro-based products saw a 10.5% year-on-year rise.