Cadila Healthcare hit a new high of Rs 510, up 4% on BSE in early morning deals, after the company received Establishment Inspection Report (EIR) from the US health regulator for its Baddi facility in Himachal Pradesh.
“The company’s manufacturing facility at Baddi has received an Establishment Inspection Report from the United States Food and Drug Administration
(USFDA)”, Cadila Healthcare said in a BSE filing.
This receipt of EIR indicates successful closure of 483s raised based on the inspection carried out between February 21 to March 1, 2017, it added.
In the separate regulatory filing, the company said Zydus Cadila has received final approval from the USFDA to market Mirtazapine orally disintegrating tablets USP in strengths of 15 mg, 30 mg & 45 mg.
The drug is an anti-depressant and will be produced at the group’s formulations manufacturing facility at Baddi.
Last week, on June 2, Cadila Healthcare said it has received USFDA approval for an antibacterial injection from its Moraiya plant, indicating an end to its regulatory problems.
“This is significant as it marks the beginning of the approval process for the filings made from the Moriya manufacturing plant after successfully completing the USFDA audit from Fed 6-15 2017 with Zero 483 observations,” the company said.
In past eight trading days, the stock has outperformed the market by gaining 17% as compared to 1.8% rise in the S&P BSE Sensex.
At 9:38 am; it was up 2.2% at Rs 501 on BSE against a marginal 0.03% decline in the benchmark index. A combined 777,233 shares changed hands on the counter on BSE and NSE so far.
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