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8 observations from USFDA may weigh on Dr Reddy's Lab

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Last Updated : Aug 21 2019 | 9:04 AM IST

Dr Reddy's Laboratories said that the audit of Formulations Manufacturing plant (Vizag SEZ Plant 1) at Duvvada, Visakhapatnam by the US FDA, has been completed and it was issued a Form 483 with 8 observations. The company will address them comprehensively within the stipulated timeline. The announcement was made after market hours yesterday, 20 August 2019.

Sun Pharma Advanced Research Company (SPARC) said that a complaint has been filed by Abraxis Biosciences LLC in the U.S. District Court for the District of New Jersey, which alleges that SPARC's filing of New Drug Application (NDA) for Taclantis injection (Paclitaxel Injection Concentrate for Suspension) is an act of infringement of the Orange Book listed patents for Abraxane. The announcement was made after market hours yesterday, 20 August 2019.

Alembic Pharmaceuticals said that the company's Bioequivalence Facility located at Vadodara was inspected by US Food & Drug Administration (USFDA) between 12 August 2019 to 16 August 2019 and between 12 August 2019 to 20 August 2019 for Bioequivalence Bioanalytical and Bioequivalence Clinical. There were no 483s issued by USFDA at the end of the inspection. The announcement was made after market hours yesterday, 20 August 2019.

SpiceJet will shift its entire Mumbai operations to Terminal 2 of the city's Chhatrapati Shivaji Maharaj International Airport with effect from 1 October 2019. The transition is being proactively planned and implemented by the airline with the active support of Mumbai International Airport Limited (MIAL) to enhance passenger convenience. . It will lead to better synergies and cut down costs substantially for the airline. The announcement was made after market hours yesterday, 20 August 2019.

Zensar announced that it has collaborated with Aptos, a recognized market leader in retail technology solutions, to support Aptos' development of next-gen cloud applications. With over 1,000 retail brands in 65 countries leveraging Aptos technology, the software vendor will utilise Zensar's expertise in digital solutions and services to accelerate and extend its research and development and professional services capabilities. The announcement was made after market hours yesterday, 20 August 2019.

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First Published: Aug 21 2019 | 8:37 AM IST

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