FDC subsidiary secures UK MHRA approval for Atropine 1.0% eye drops
FDC Limited’s subsidiary, FDC International Limited, received marketing authorisation from the UK’s MHRA for Atropine 1.0% w/v Eye Drops. The regulatory clearance allows the company to commercialise the ophthalmic solution in the United Kingdom. The development was disclosed via an exchange filing on August 13, 2026.
*this image is generated using AI for illustrative purposes only.
FDC Limited has secured marketing authorisation for its ophthalmic product Atropine 1.0% w/v Eye Drops in the United Kingdom. The regulatory clearance was granted to the company’s subsidiary, FDC International Limited, by the Medicines and Healthcare products Regulatory Agency (MHRA).
Approval details
The MHRA approval enables FDC International Limited to market the Atropine 1.0% w/v Eye Drops, Solution in the UK. The intimation was disclosed to stock exchanges on August 13, 2026, under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
| Parameter: | Details |
|---|---|
| Product: | Atropine 1.0% w/v Eye Drops, Solution |
| Market: | United Kingdom |
| Regulator: | Medicines and Healthcare products Regulatory Agency (MHRA) |
| Approved Entity: | FDC International Limited (Subsidiary) |
| Approval Type: | Marketing Authorisation |
How is FDC Limited planning to differentiate its Atropine 1.0% offering from existing competitors in the UK ophthalmic market?
What is the projected revenue contribution from this product launch for FDC International Limited in the next fiscal year?
Are there plans to seek regulatory approvals for this Atropine formulation in other European markets following the MHRA clearance?
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