Drug Approval | March 27, 2023
Briefs: Morepen Laboratories and Zydus Lifesciences
The company is addressing these observations
The company is addressing these observations
The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
Pfizer’s total cumulative revenue from Seagen therapies is expected to reach $36 billion by 2028, according to GlobalData, a leading data and analytics company.
The patent was granted for creating a green catalyst for one of the world's most significant chemical reactions
Doxepin Hydrochloride capsule is indicated to treat mental/mood problems such as depression and anxiety
Lubiprostone capsule is indicated to treat certain types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation)
Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).
PM emphasises the need to enhance lab surveillance & testing of all Severe Acute Respiratory Illness (SARI) cases & ramp up genome sequencing
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
The audit is a pre-approval inspection for three products filed from the facility
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