Hyderabad: City-based Neuland Labs recently said that the US health regulator has issued a total of 5 observations after inspection of its Unit 1 manu...
News
Novartis, Glenmark enter partnership to commercialize, distribute respiratory drugs Seebri, Onbrize, Ultibro
Under the terms of the agreement, Novartis will remain the holder of the registration of the drugs Seebri, Onbrize and Ultibro and will be responsible...
Alembic Pharma gets USFDA nod for Bromfenac Ophthalmic Solution
The approved product, Bromfenac Ophthalmic Solution is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution, 0.0...
Dr Reddys gets two USFDA observations for Vizag plants
Hyderabad: City-based Dr Reddy’s Laboratories (Dr Reddys/ DRL) has reportedly fallen under the US health regulator’s scanner. The company ...
Glenmark Pharma Ryaltris gets Complete Response Letter from USFDA
The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, Glenmar...
GSK Pharma to optimise product portfolio to drive growth in India
GSK is also looking to launch some new products in the country over the next 15 months as it adopts a more structured approach to engage trade channel...
Refix ceiling price of Zydus Healthcare Tiotropium Inhalation: DoP directs NPPA
New Delhi: Allowing the review petition of Zydus Healthcare Limited regarding price fixation of Tiotropium Inhalation (MDI) 9 mcg/dose, the Department...
No formal warning issued from AIIMS regarding adverse effects of e-cigarettes: Minister informs Parliament
In response to a question on whether AIIMS has issued any warning regarding harmful effects of e-cigarettes, he said the premier medical institute has...
USFDA declines to approve Daiichi Sankyo blood cancer treatment Quizartinib
The decision follows an advisory committee meeting, held in May, where independent advisers to the U.S. regulator voted 8-3 against the drug’s a...
Sanofi, Google team up to discover better treatments
Sanofi and Google will use data sets to improve their understanding of key diseases and extract patients’ insights and feedback, the companies s...
