Zydus Cadila receives final approval from the US FDA for Tizanidine Hydrochloride capsules
Cadila Healthcare has received final approval from the US FDA to sell Tizanidine Hydrochloride capsules in the US. Estimated sales for these capsules in the US over the last twelve months was $58.6 million. The company will be manufacturing these capsules at the SEZ facility in Ahmedabad. Press Release
We enclose herewith a copy of press release dated March 8, 2017, titled Zydus Cadila receives final approval from the USFDA for Tizanidine Hydrochloride Capsules. Outcome of Board Meeting
Pursuant to SEBI [Listing Obligations and Disclosure Requirements] Regulations, 2015, we inform that the Board of Directors at their meeting held today approved the payment of interim dividend at Rs.3.20/- per equity share on 1,023,742,600 Equity Share of Rs.1/- each for the Financial Year 2016-17. The Board of Directors in above meeting also fixed March 17, 2017 as the Record Date to ascertain the list of members entitled to receive the interim... Press Release
We enclose herewith a copy of press release dated March 7, 2017, titled Zydus announces settlement with Supernus on Trokendi XR (topiramate) extended-release capsules. The contents of the press release give full details. Please bring the aforesaid news to the notice of the members of the exchange and the investors' at large. US regulator observations at Baddi unit may not effect Cadila
Ahmedabad-headquartered Cadila Healthcare has today informed the Bombay Stock Exchange (BSE) that its Baddi plant has received three observations from the US Food and Drug Administration (USFDA) related to a pre-approval inspection (PAI) for a specific product filed. While the company's shares on the BSE tanked 1.76 per cent in day's trade, analysts say this would have no immediate impact on revenues. Cadila Healthcare said in its statement that the USFDA had inspected its formulations manufacturing facility at Baddi from February 20 to March 1 and at the end of the inspection, there were three observations given under form 483. "All these three observations are related to Pre-Approval Inspection (PAI) for a specific product filed. This product is yet to be manufactured or marketed in the US. The company is already in the process of responding to the PAI observations. Apart from above product related observations, there are no observations related to cGMP practices," it said.As per... Cadila Healthcare facility in Baddi receives three observations from FDA
The USFDA inspected Cadila Healthcare's formulations manufacturing facility at Baddi over the last ten days, starting February 20th. At the end of the inspection, there were 3 observations given by the FDA to the facility under form 483. All three observations, Cadila says, are related to Pre-Approval Inspection (PAI) "for a specific product filed". This product is yet to be manufactured or marketed in the US, but is pending approval with the FDA. Press Release
Dear Sir / Madam, We wish to inform that the USFDA inspected our formulations manufacturing facility at Baddi from 20th February 2017 to 1st March 2017. At the end of the inspection, there were 3 observations given under form 483. All these three observations are related to Pre-Approval Inspection (PAI) for a specific product filed. This product is yet to be manufactured or marketed in the US. The company is already in the process of responding... Credit Rating
Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, we enclose herewith a copy of CRISIL rating A1+ on the 250 crores Short Term Debt Programme (including Commercial Papers) of the Company. Newspaper Advertisements for Notice convening the meetings of the Equity Shareholders, Secured Creditors and Unsecured Creditors
Cadila Healthcare Ltd has submitted to BSE a copy of Newspaper Advertisements published in newspaper regarding notice convening the meetings of the Equity Shareholders, Secured Creditors and Unsecured Creditors of the Company scheduled on March 30, 2017. Zydus Cadila to launch tetravalent influenza vaccine in India
Vaccine offers protection from 4 influenza viruses - H1N1, H3N2, Type B (Brisbane) & Type B (Phuket)