Drug Approval | March 22, 2023
Granules Consumer Health concludes FDA audit with zero observations
The audit is a pre-approval inspection for three products filed from the facility
The audit is a pre-approval inspection for three products filed from the facility
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)
Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.
The facility has been set up to manufacture tuberculosis testing cartridges
Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.
The company will be submitting the responses to US FDA observations within stipulated timeline
Olanzapine Orally Disintegrating Tablets are used to treat certain mental/mood conditions
Erythromycin Tablets USP, 250 mg and 500 mg are used to prevent and treat infections in many different parts of the body
The Development Center with its state-of-the art laboratories and flexible pilot capacities is set to become Siegfried's global research and development hub for its Drug Products sites, strengthening the global network
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