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Results For "approval"

2476 News Found

Capnopharm receives CE certification for its new CapnoPen technology
News | May 31, 2023

Capnopharm receives CE certification for its new CapnoPen technology

Capnopharm’s new CapnoPen is the first PIPAC nebulizer to obtain CE marking under the new MDR regulation 2017/745


Lincoln Pharmaceuticals posts FY23 PAT at Rs. 72.90 Cr
News | May 26, 2023

Lincoln Pharmaceuticals posts FY23 PAT at Rs. 72.90 Cr

For Q4 ended FY23, company reported net profit of Rs. 12.56 crore as against net profit of Rs. 11.02 crore in the corresponding period last year


Venus Remedies gets Kenyan GMP certification for its manufacturing facilities in Baddi
Drug Approval | May 24, 2023

Venus Remedies gets Kenyan GMP certification for its manufacturing facilities in Baddi

The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans


Lonza launches TheraPEAK T-VIVO cell culture medium to accelerate cell therapy development
News | May 24, 2023

Lonza launches TheraPEAK T-VIVO cell culture medium to accelerate cell therapy development

Lonza launches the TheraPEAK T-VIVO Cell Culture Medium with a novel chemically defined formulation developed to optimize and streamline CAR T-cell manufacturing


Strides Puducherry facility receives EIR  from USFDA
Drug Approval | May 20, 2023

Strides Puducherry facility receives EIR from USFDA

The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.


Hikal announces USFDA audit with zero observations
Drug Approval | May 16, 2023

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites


Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute
News | May 15, 2023

Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute

Dr. Reddy's Laboratories has been issued a Form 483 with four observations


USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause
Drug Approval | May 13, 2023

USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause


USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’
Drug Approval | May 12, 2023

USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time


Sanofi India to demerge healthcare businesses
News | May 12, 2023

Sanofi India to demerge healthcare businesses

This decision will accelerate growth for both its pharma & consumer healthcare businesses in India