The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited
The company sees the business reaching $100mn
Formulation revenue decreased by 7.6% YoY to Rs. 4,770 crore whereas in Q2 FY23, API business posted a growth of 24.2% YoY with revenue of Rs. 969.4 crore
The core of “LANXESS Biosecurity Solutions” is a portfolio of scientifically formulated, highly effective and versatile biocidal products
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
Revenue is up 23% whereas Profit After Tax expands 29% for the company
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US
The company's long-term strategy is on science, technology and innovation and the company's strategy relating to this is on track
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