Game-changing EDQM certification propels SMS Pharmaceuticals into Europe’s Ibuprofen market

SMS Pharmaceuticals Limited has officially received the coveted EDQM certification, a milestone that positions the Indian-based pharmaceutical giant to supply Ibuprofen to European markets. The European Directorate for the Quality of Medicines & HealthCare (EDQM) awarded this certification following a rigorous inspection of SMS Pharma’s Visakhapatnam facility. Conducted between February 28th and March 1st, 2024, the inspection validated the company’s adherence to the stringent Quality Management System based on the EU’s Good Manufacturing Practices (GMP) for pharmaceutical products.

The certification marks a significant achievement for SMS Pharmaceuticals, which has steadily carved out a global presence in the active pharmaceutical ingredient (API) market since its establishment in 1990. The approval is crucial as it grants SMS Pharma access to one of the most regulated markets in the world, opening the doors to further expansion within Europe.

Commenting on this accomplishment, SMS Pharmaceuticals’ Executive Director, P. Vamsi Krishna, emphasized the importance of this milestone in reinforcing the company’s commitment to global quality standards. He highlighted that the certification underscores the dedication and hard work of the entire team at SMS Pharma, solidifying their reputation as a reliable partner in the pharmaceutical industry.

Commitment to Global Standards

The successful inspection of the Visakhapatnam (Vizianagaram) facility demonstrated SMS Pharmaceuticals’ unwavering commitment to maintaining high-quality standards, a cornerstone of the company’s business strategy. The European Directorate’s certification is known for its strict guidelines, and companies that achieve it must demonstrate compliance with the most advanced production protocols in the pharmaceutical industry.

This EDQM certification not only allows SMS Pharma to supply Ibuprofen to the European Union but also serves as a seal of trust that will likely influence other international markets, potentially opening up new revenue streams in untapped regions.

Expert Opinion: Navigating Global Regulatory Waters

Industry experts consider this certification an essential step for SMS Pharmaceuticals as it continues its strategic push for market leadership. According to a prominent pharmaceutical analyst, global expansion in regulated markets like Europe requires a combination of innovation, consistency in quality, and compliance with international standards. The EDQM certification checks all these boxes for SMS Pharma, potentially positioning the company as a strong contender in the high-demand Ibuprofen market across Europe.

The analyst further remarked that achieving such certifications helps pharmaceutical companies secure long-term partnerships with major global healthcare providers, which can ultimately boost both their market share and revenue.

A Testament to In-House Capabilities

SMS Pharmaceuticals is not new to global markets. With two state-of-the-art manufacturing facilities in Hyderabad and Vizianagaram, the company’s manufacturing capabilities are robust, featuring a total capacity of 3,200 KL. These plants are supported by strong in-house R&D capabilities, which play a vital role in producing quality APIs and pharmaceutical intermediates across a diversified portfolio of therapeutic segments.

The company’s commitment to innovation and consistent delivery of quality products has allowed it to build a trusted relationship with global customers across over 70 countries. The EDQM certification will further bolster this reputation, making SMS Pharmaceuticals an even more attractive partner to pharmaceutical companies across Europe and beyond.

Future Growth and Expansion

The attainment of the EDQM certification is more than just a validation of SMS Pharmaceuticals’ operational standards; it also positions the company for future growth. With Europe now accessible for Ibuprofen supply, SMS Pharmaceuticals can focus on scaling its operations to meet increased demand. It is likely that this milestone will spur the company to pursue further certifications for other products in its portfolio, expanding its reach into new markets.

For SMS Pharmaceuticals, the road ahead looks promising. As the pharmaceutical landscape continues to evolve, the company’s dedication to quality, innovation, and global expansion puts it on a strong trajectory for continued success.