FDC Limited announced that its subsidiary, FDC International Limited, has received marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its Atropine 1.0% w/v Eye Drops, Solution. This approval marks a significant milestone for the company’s expansion into the European market and is expected to boost its international pharmaceutical offerings. The company has submitted this information in accordance with SEBI Listing Regulations.
International Expansion Milestone
FDC Limited has achieved a significant milestone in its global market penetration strategy with the announcement of a crucial regulatory approval in the United Kingdom. The company’s subsidiary, FDC International Limited, has successfully obtained marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory body of the UK.
Product and Market Focus
The authorization pertains to the product Atropine 1.0% w/v Eye Drops, Solution. This approval signifies a key step for FDC in establishing its presence in the European pharmaceutical market. The acquisition of marketing authorization from the MHRA will enable the company to commercialize this ophthalmic product in the United Kingdom, further diversifying its international revenue streams and strengthening its product portfolio.
Regulatory Compliance
This intimation is being made in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company considers this development to be of material importance to its stakeholders, indicating progress in its international business operations and product approvals.
Source: BSE
