Shilpa Medicare Receives EU GMP Approval for Bengaluru Manufacturing Unit

8 May 2025 , 12:30 AM

Shilpa Medicare Ltd on May 6, 2025 issued a statement that it has been awarded the Good Manufacturing Practice (GMP) certificate by the European Medicines Agency (EMA) for Unit VI manufacturing facility at Dabaspet, Bengaluru.

The certification came after a successful inspection by the Finnish Medicines Agency on behalf of EMA from March 10 to March 14, 2025. The audit concluded with a few minor observations, reflecting strict compliance with international pharmaceutical manufacturing standards.

GMP clearance includes manufacturing, packaging, testing, storing, and distribution of two novel dosage forms of medicines—Oral Mouth Dissolving Films and Transdermal Systems.

The novel dosage forms are distinguished by technology-based, specialty uses, providing benefits such as improved patient convenience, improved dosing compliance, and faster or extended delivery of the drug. Unit VI facility is also cleared by other leading regulators such as the MHRA (UK) and the TGA (Australia).

Shilpa Medicare is also exporting Oral Film products to the United States and other foreign countries, which is a testament to the international quality standards of the unit.

With the fresh EMA accreditation, the company is now well-positioned to further consolidate its presence in the European Union, especially in the Oral Films and Transdermal Patches markets.

Shilpa Medicare again stated that it has a strong pipeline of products in these strength forms with several products already approved, under the review process, or in final stages of development. The approval by EMA will be an important growth catalyst, allowing the company to expand further its business in Europe’s regulated markets and leverage its R&D and manufacturing strengths.