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Ahmedabad: Zydus Lifesciences has informed in a BSE filing that the Company has received a Warning Letter from the US Food and Drug Administration (USFDA) relating to the Injectables manufacturing facility at Jarod near Vadodara.
The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. It does not contain any data integrity related violations.
Earlier in July, the Company had received OAI status from the USFDA. The inspection which was conducted from April 15 to April 23, 2024.
Read also: Zydus Lifesciences gets USFDA OAI status for Jarod facility
“The contents of the Warning Letter shall be made public by the USFDA in due course,” the Company stated.
“The Company will take all necessary steps to work with USFDA towards earliest remediation of the above facility,” it added.
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
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Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Scopolamine Transdermal System 1 mg/3 days. (USRLD: Transderm Scop Transdermal System 1 mg/3 days).
This is the fifth ANDA approval for Zydus in the transdermal portfolio.
Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus has been actively discovering and developing New Chemical Entities (NCEs) novel biologicals, several biosimilars and vaccines as a part of its innovation pipeline. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
Read also: Zydus Lifesciences to buy 50 percent stake in Sterling Biotech from Perfect Day
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Mumbai: A 28-year-old police constable allegedly died following an anaesthesia overdose at Axis Hospital in Lokhandwala in the western suburb of Andheri. She had been admitted to the hospital for ear surgery.
The incident took place when Patil was administered anaesthesia before her ear surgery. She developed complications and died on Thursday night, according to the official.
He said that Constable Gauri Subhash Patil was admitted to Axis Hospital in Lokhandwala in the western suburb of Andheri.
According to the PTI report, the police were informed about the death around 10.45 pm, he said.
As per a media report in the TOI, She was admitted in the private hospital “because some fluid was oozing out of her right ear,” said her brother Vinayak.
Her pulse and BP dropped soon after she was administered anaesthesia and she passed away a little while later, he added.
The body has been sent for post-mortem to ascertain the cause of death, he said.
A case of accidental death has been registered at Amboli police station, and a probe is on, the official said, news agency PTI reported.
The deceased’s family stated that the cause of her death would be determined only after the post-mortem, which was conducted at Cooper Hospital in Juhu on Friday.
Patil was posted with the local arms division of the Mumbai police at Marol in Andheri.
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Hyderabad: The state-run oldest government hospital, Osmania General Hospital in Hyderabad will soon have a new building constructed on 32 acres of land currently occupied by the Goshamahal Police Stadium.
Chief Minister A. Revanth Reddy on Tuesday made the decision to transfer the land from the Goshamahal Police Stadium and Sports Complex to the Department of Medical and Health.
According to an IANS report, he asked the officials to expedite the process for construction of the new building of the hospital as he reviewed various development projects under the Smart Proactive Efficient and Effective Delivery (SPEED) programme.
Also Read:Osmania General Hospital inaugurates first state-run transgender clinic
Health Minister Damodar Rajanarasimha, Chief Secretary Santhi Kumari and other officials attended the meeting.
Nineteen projects under SPEED include the construction of a new building of the Osmania Hospital, the establishment of 15 new nursing colleges, 28 new paramedical colleges, and the construction of samakhiya bhavans in districts.
The Chief Minister wanted the officials to keep in mind the needs of the next 50 years while designing the new building of Osmania Hospital. He asked the officials to prepare plans for roads to ensure that people coming to the hospital from various places do not face any traffic problems, news agency IANS reported.
He said in addition to blocks for all departments, academic blocks and hostels for nursing staff should be constructed.
The Chief Minister said the hospital should provide healthcare facilities in all specialities at par with the corporate hospitals.
He also said the government would protect the present building of the Osmania Hospital as a heritage structure. He said the building would be preserved as part of the Musi River Development Project to attract tourists.
A proposal by the previous BRS government to demolish the present building of Osmania Hospital to build a new structure was strongly opposed by historians, heritage activists, and citizens concerned. The move was also challenged in the High Court.
Conceived after the Musi floods of 1908, the Osmania Hospital was built by Mir Osman Ali Khan, the last Nizam of Hyderabad State and named after him. Designed by British architect Vincent Jerome Esch and Nawab Khan Bahadur Mirza Akbar Baig in the Indo-Saracenic style, it was completed in 1919. Heritage experts say the domes of Osmania Hospital added to Hyderabad’s charms.
Spread over 26.5 acres, the hospital has 11 major blocks. The in-patient block alone was over an area of 2.37 acres with a total bed capacity of 1,168 beds including 363 in super-speciality wards.
Chief Minister Reddy also instructed that the police department be allocated alternative land for the Goshamahal complex. He asked the district collector to assess the feasibility of relocating the Police Stadium and Sports Complex to land around the Police Transport Organisation and City Police Academy at Petla Burj.
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