Drug Approval | June 17, 2025
USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
The company received one observation in the Form-483
The company received one observation in the Form-483
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
Laurus Synthesis receives Form 483 with 5 observations from USFDA
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
The company will be submitting the responses to US FDA observations within stipulated timeline
Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties
The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)
Subscribe To Our Newsletter & Stay Updated
