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…
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Browsing Tag
API
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…
Mankind Pharma to open two plants by mid-2016
The company will invest Rs 200 crore to open plants in Sikkim and Rajasthan Mankind Pharma will invest Rs 200 crore to open two…
US FDA warns of serious data integrity violations at DRL
The US Food and Drug Administration has warned DRL over serious data integrity violations, placing all its new applications or…
DRL issues statement on receipt of warning letter from US FDA
The company has received warning letters for API manufacturing and oncology formulation manufacturing facilities at Andhra Pradesh…