he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice
IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma
This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence
The transaction enhances Roquette’s ability to deliver high-value drug delivery solutions to pharmaceutical customers worldwide
Over the last 24 years, the company's sales has grown from Rs. 478 crores to Rs. 19,022 crores
Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,
These observations are procedural in nature and none of them are related to data integrity
The FDA issued Form 483 with one observation related to building and facility management
This partnership marks a significant milestone in Sigachi's strategy to expand into advanced drug delivery technologies.
The Subsidiary has received one inspectional observation in Form 483
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