Akums Drugs Secures EU-GMP Certification for Two Haridwar Plants
New Delhi: Akums Drugs and Pharmaceuticals Limited has received European Good Manufacturing Practice (EU-GMP) certificates for its two manufacturing facilities, Plant 1 and Plant 2, both located at Haridwar, Uttarakhand, marking a key regulatory milestone for the company. While the certification for Plant 1 is a renewal of its existing EU-GMP approval, Plant 2 has received EU-GMP certification for the first time.
In a regulatory filing, the company said the disclosure has been made under Regulation 30 read with Part A of Schedule III of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
As per the details disclosed, the regulatory authority granting the certification is the Bulgarian Drug Agency (BDA). The EU-GMP certificates have been granted for a period of three years, and will remain valid until October 2028.
The company stated that these approvals are strategically significant as they will enable Akums to cater to EU-regulated markets and pursue new business opportunities in European countries, as well as other global markets that follow EU-GMP standards.
With the grant of EU-GMP certification, Plant 1 at Haridwar is now authorised to manufacture and supply tablets, hard gelatine capsules and sachet dosage forms for EU markets. Meanwhile, Plant 2 has been authorised to manufacture and supply oral liquid formulations for EU countries. The company further clarified that the European CDMO contract signed by Akums in December 2024 will be serviced from Plant 2.
Akums also confirmed that there has been no withdrawal, cancellation or suspension of any licence or approval by the regulatory authority, and that there is no estimated monetary or operational impact arising from any regulatory action. The company added that there are no corrective actions required, as the approvals remain valid.
