Novartis India Ltd has announced with reference to a newspaper publication in 'Mint' on July 12, 2018 regarding issuance of a show cause notice by drug licensing authority to Themis Medicare Limited (Themis), who is a manufacturer of Diclofenac 1 ml injection for Novartis India Limited (Company).
In this context, it may be noted that Themis has intimated the Company on July 12, 2018 that they are in receipt of a show cause notice dated July 11 , 2018 from the drug licensing authority at Daman, wherein they were directed to not manufacture the said product until the matter is decided.
Themis has been manufacturing Diclofenac 1 ml injection under Voveran brand since 2015 and has been marketed by the Company in India based on regulatory approvals granted to them earlier. The Company has sold over 110 million ampoules of this SKU with no serious adverse events reported.
We also understand that Themis is independently pursuing a writ petition already filled by them in the Delhi High Court pertaining to the said issue.
Novartis is committed to providing patients with high quality medicines and patient safety is at the core of everything we do.
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