Drug Approval | June 16, 2023
Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
The company will submit its comprehensive response on these observations to the US FDA
The company will submit its comprehensive response on these observations to the US FDA
Collaboration to accelerate and de-risk clinical development of Nanopharmaceutics CNS portfolio
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
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
Survey of Unmet Needs in chronic myeloid leukemia (CML SUN) data signal need for amplified patient voice during treatment discussions that balance quality of life (QoL), efficacy, and tolerability goals across all lines of therapy
The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement
Lantern is receiving an exclusive and worldwide option to license intellectual property from Bielefeld University related to the collaboration and IP generated from the collaboration
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)
New facility will strengthen the security of supply for global pharmaceutical and biotech customers and will support the continued development and production of lifesaving clinical and commercial-scale therapeutics for patients worldwide.
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
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