In a stock exchange filing, the pharmaceutical company said that it has been awarded the GMP certification by the European Medicines Agency (EMA) following the successful closure of an inspection at Unit VI located in Dabaspet in Bengaluru.
The inspection was conducted by the Finnish Medicines Agency on behalf of EMA from March 10 to March 14 and it concluded with a few minor observations, Shilpa Medicare said.
The GMP approval awarded to the pharmaceutical company’s facility is for the manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms being produced from this unit.
The two complex dosage forms being produced at Unit VI, Dabaspet, are Oral Mouth Dissolving Films and Transdermal Systems. The Unit is already approved by the MHRA, UK, and the TGA, Australia.
The company has stated that Oral Mouth Dissolving Films and Transdermal Systems are both technology-intensive, niche and complex dosage forms that offer significant advantages over conventional oral dosage forms in terms of patient convenience, dosing compliance and quick or sustained drug delivery for local and systemic therapy.
The said unit (Unit VI) is currently supplying Oral Film products to the United States and other markets.
The approval received from EMA will help Shilpa Medicare to secure approval and market its range of Oral Film products and Transdermal Patches in the entire European Union.
“The Company has a pipeline of products under the Oral Film and Transdermal Patch dosage forms, which are approved, under approval and in advanced stages of development,” Shilpa Medicare said in a press release dated May 6.
Shares of Shilpa Medicare were trading 1.84% lower at ₹655.45 apiece on the BSE at 12:43 pm.
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