USFDA issues Form 483 with five observations to Biocon’s Bengaluru facility
Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in…
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Browsing Tag
API
Budget 2020: What does the industry want?
Last year in July, Finance Minister Nirmala Sitharaman presented the first Budget of Modi Government 2.0. Since the pharmaceutical…
Why API price needs to be part of NPPA’s pricing formula
The over-dependence on China and other countries imperils not just the health of the pharma industry in India, but also that of…
Cipla announces closure of USFDA inspection at Bengaluru facility
Following an inspection by USFDA at the company’s API manufacturing facility in Virgonagar, from July 15 to 19, the company has…
USFDA pulls up Lantech Pharma for manufacturing violations at Andhra plant
The significant violations included the failure of the quality unit to ensure that quality-related complaints were investigated…
Warning letter woes: Dr Reddy’s expects FDA inspection of AP plant by year-end
The company's API plant at Miryalaguda was given an Establishment Inspection Report (EIR) in 2017 resolving the earlier warning…
Biocon Q1FY20 Revenue grows by 25 per cent
EBITDA up 51 per cent at Rs 462 crores, net profit (excluding exceptional item) up 86 per cent at Rs 223 crores, small molecules…
US FDA issues 5 observations to Dr Reddy’s plant in Hyderabad
The company has been issued a Form 483
Dr Reddy's Laboratories said the US health regulator has issued five observations after…
FDA pulls up Aurobindo Pharma for ‘repeated’ failures in CGMP
The FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from…
Natco Pharma suspends work at Chennai plant due to flood
Company's API plant has temporarily suspended operations due to rains
Drug firm Natco Pharma said its active pharmaceuticals…