The 'Official Action Indicated' status may cause product approvals to be delayed or withheld.
The Hamied family's eventual exit from the pharma company will begin.
The drugmaker's EBITDA, increased 15.5% year-on-year to Rs 3,332 crore in the quarter.
Investors are anticipating the announcement of the drugmaker's quarterly results on July 26.
The name of the biotechnology firm and other terms of the agreement were not disclosed.
Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) are bioequivalent to Advil Dual Action Tablets.
Lupin’s Indore Unit 2 facility received the warning letter in November 2017.
The product will be developed at the group's Baddi facility in Himachal Pradesh.
BFI-751 is being developed as a biosimilar to Stelara (Ustekinumab).
There were no reported adverse events for Albuterol Sulphate Inhalation Aerosol.
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