Pinnacle Is All Set to Export Its Formulations to the UK Market
Pinnacle Life Science, a Subsidiary of Aarti Drugs Ltd, yet again accomplished another achievement on October 2, 2024, as they received the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Good Manufacturing Practice (GMP) Compliance Certificate. The accreditation comes after a thorough audit, which was conducted in June 2024. This acquisition reflects Pinnacle's dedication in producing pharmaceutical products that meet the highest international quality and safety standards.
Pinnacle's General Oral Solids facility in Baddi is a world-class manufacturing hub designed to meet and exceed global regulatory requirements. Prior to receiving the UK MHRA certification, this facility had already earned approvals from other respected regulatory agencies, including PIC/s, MCAZ, Digemid-Peru, NDA, TFDA, and EFDA. The plant is equipped with current Good Manufacturing Practice (cGMP) compliant equipment, automated production processes controlled via Programmable Logic Controllers (PLCs), and sophisticated software to maintain strict quality management systems (QMS) and laboratory activities.
Pinnacle Life Science has consistently exceeded its benchmark in terms of its quality and compliance guidelines. By accomplishing the certification, it is now all set to import its formulations with the latest GMP Compliance Certificate to the UK market. They have also now broadened its access to other regulated markets that recognize UK standards, including Canada, Australia, New Zealand, and South Africa. With an exciting pipeline of over 20 molecules ready for commercialization across these regulated markets, Pinnacle is well-positioned to make a detrimental way forward in its international growth. Some products in the pipeline include the Sitagliptin range, Dapagliflozin and combinations, Empagliflozin and combinations, Apixaban, and Rivaroxaban.
"Our goal has always been clear and simple. We want to make quality, patient-centric medicines that can meet the needs of the market. Surely, we also want to expand in the international market, and for that, my team and I are dedicated to deliver the highest quality standards across our operations, starting from R&D to our quality assurance checks. We are just getting started with the UK MHRA GMP Certificate; we have a lot more to achieve and accomplish", said Vishwa Savla, the Founder and Managing Director.
Pinnacle Life Science has also received the prestigious US FDA approval for its Oncology Facility in Baddi earlier this year. A top-notch structure quality policy and system have been implemented on all units of Pinnacle, preparing it to advance its position as a market leader by competing in the worldwide pharmaceutical market.
About Pinnacle:
Pinnacle Life Science Pvt. Ltd, a subsidiary of Aarti Drugs Ltd, is an emerging global name in the pharmaceutical industry. Aarti Drugs Ltd. has an annual turnover exceeding Rs. 5000 Cr specialising in bulk APIs and intermediates. This contributes to Pinnacle's finished formulations and dosages, supported by two state-of-the-art cGMP-compliant manufacturing facilities in India. Spanning a 35-year legacy in healthcare and an annual production capacity of 3 billion tablets and 300 million capsules, the company boasts a comprehensive portfolio of medications for acute and chronic ailments, including specialized areas such as Anti-Diabetic, Anti-Cancer, and Anti-Hypertensive treatments. The company's global presence is across North and Latin America, Europe, Africa, Asia, and beyond. The company partners with over 250 clients worldwide, emphasizing collaborative growth through diverse business models such as licensing, co-development, contract manufacturing, and tech transfer.
