The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
The company is already marketing the 4 mg and 10 mg strengths
Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024
The company will submit its comprehensive response on these observations to the USFDA
The investment is part of Croda’s continuing commitment to develop high performance pharmaceutical ingredients and technologies for life sciences.
This patent-pending, high-efficiency chromatography media is used for the purification of novel peptide-based pharmaceuticals in the GLP-1 agonist class including type 2 diabetes and obesity treatments
The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
The inspection closed with zero observations
Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
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