Granules India Limited has announced that its Unit V facility, located in Anakapally, Visakhapatnam, Andhra Pradesh, has been awarded the European Union Good Manufacturing Practice (EU GMP) certificate. This certification marks a significant milestone in the company’s compliance with international pharmaceutical manufacturing standards.
Regulatory Approval from EU Authorities
The certification was granted following an audit conducted in November 2024 by the National Centre for Public Health and Pharmacy, Hungary. The EU GMP certification is a crucial regulatory requirement for exporting pharmaceutical products to European markets, ensuring that the facility meets stringent quality and safety standards.
Scope of Unit V Operations
The Unit V facility plays a key role in the company’s manufacturing capabilities, focusing on the production of both Active Pharmaceutical Ingredients (APIs) and Finished Dosages (FDs). The facility is involved in manufacturing formulations for oncology and non-oncology products, broadening the company’s product portfolio in critical therapeutic areas.
Strategic Importance of EU GMP Certification
Securing an EU GMP certificate enhances Granules India’s ability to supply pharmaceutical products to European markets, demonstrating its commitment to global regulatory compliance. This certification may help the company strengthen its presence in regulated markets and explore new business opportunities in the EU pharmaceutical sector.
Financial Performance of Granules
Granules India stated in a regulatory filing that its consolidated profit after tax decreased by 6% year-on-year to ₹118 crore for the third quarter ended 31 December 2024.
The company had reported a profit after tax of ₹126 crore during the October-December quarter of the previous financial year.
Revenue from operations declined to ₹1,138 crore in the third quarter, compared to ₹1,156 crore in the corresponding period last year.
On January 30, 2025, at 9:39 AM, Granules India shares traded at ₹554.15 per share on the NSE.
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