Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
Ryan has nearly 20 years of global legal and IP expertise in the pharmaceutical industry
The instrument is fully integrated with Lonza’s latest WinKQCLSoftware to enable data integrity compliance, streamline training, and reduce validation burden
US FDA approval is in line with de-risking strategy for additional API site to service our global customer base
Qualifyze specializes in Good Practice audits (GxP) audits and covers a wide range of areas, including excipients, starting materials, packaging, sustainability
Chintan Shivir has provided a platform to hold discussions with higher officials and experts, which will help in evolving better practices of premier health institutions like AIIMS
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
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