|
| Exchange Received Time 21/06/2019 19:37:03 Exchange Disseminated Time 21/06/2019 19:37:07 Time Taken 00:00:04 | With reference to your email dated June 21, 2019 seeking clarification on the news item in https://www.business-standard dated 21-Jun-2019, captioned 'Sun Pharmaceutical gets four observations for Halol facility in Gujarat', we hereby submit our responses as follows:
a) Whether such event/negotiations/article stated in published news were taking place? If so, you are advised to provide the said information along with the sequence of events in chronological order and the material impact of this article on the Company.
Response - The US FDA conducted a Pre-Approval Inspection (PAI) of Sun Pharmaceutical Industries Ltd.'s Halol facility (Gujarat, India) from June 03, 2019 to June 11, 2019. At the conclusion of the inspection, the agency issued a Form 483, with four observations. The Company will be submitting its response on the observations to the US FDA within 15 business days. Sun Pharma is committed to addressing these observations promptly.
b) Whether company are aware of any information that has not been announced to the Exchanges under regulation 30 of the SEBI (LODR) Regulations, 2015. If so, you are advised to provide the said information and the reasons for not disclosing the same to the Exchange earlier as required under regulation 30 of the SEBI (LODR) Regulations, 2015.
Response - No.
c) The material impact of this article on the Company.
Response - There is no material impact of this article on the Company.
Kindly let us know in case you require any further clarification. |
|
|