Tirzepatide is primarily indicated for the treatment of T2D and is expected to receive its decision from the FDA in Q2 2022
The unit is an oral manufacturing facility at Jedcherla, Hyderabad
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
The audit is a PAI for two of its product applications filed from this facility
Intuitive Telepresence (ITP), facilitates remote learning, and encourages interaction and collaboration between surgeons without the need to travel
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
The company does not expect the outcome of this inspection to impact its plans
The company said in a regulatory filing that it was confident of addressing the observations satisfactorily
The net proceeds from the issue will be utilised towards the purchase of machinery, modernising existing units and expansion of its R&D facilities
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