The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib Capsules, 70 mg.
Sapropterin dihydrochloride powder for oral solution is available in 100 mg unit dose
GSKP announced sale of its newly constructed manufacturing plant at Vemgal, Karnataka to Hetero Labs for a cash consideration of Rs1.8bn
Zydus has made its brand of Remdesivir, Remdac more affordable at Rs. 899 for a 100 mg lyophilized injection.
NPPA also fixed retail price of 76 new drugs in the meeting dated 10th March 2021 to be launched by existing manufacturers including off-patent Anti-diabetic drugs allowing due benefit of patent expiry to the patients.
The receipt of this permission paves way for the launch of Osimertinib 40mg/80mg film coated tablets in India.
Nitazoxanide Tablets, 500 mg (RLD: Alinia) had estimated annual sales of USD 56 million in the U.S.
Intrarosa will not only expand and strengthen our product portfolio into Women's Health in Canada but will cater to satisfy the unmet medical needs.
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