Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2
The company is addressing these observations comprehensively
The company is addressing these observations comprehensively
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility
Azelis will strengthen its presence in the domestic market by leveraging portfolio synergies, actively consolidating the business, and creating value for all stakeholders
The audit has been concluded with no major observations
The site, spanning approximately 25,000 square meters, is expected to commence operations by the end of 2025
The inspection concluded with zero Form 483 observations
Changhua site meets international regulatory standards for global medical applications
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
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