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Total 85 results found. Search for [ CGMP ]

Results 1 to 21 of 85
PTI
January 18, 2020
The USFDA inspection for the API facility at Vizag was carried out between January 13, 2020 and January 17, 2020, and it closed five 483 observations


PB Jayakumar
January 14, 2020
A couple of days ago, Lupin said that it had received two observations from the US health regulator following the inspection at its Nagpur manufacturing facility, one of its most modern plants


PTI
January 11, 2020
A Prior Approval Inspection was carried out by the United States Food and Drug Administration at Lupin's Nagpur oral solid dosage manufacturing facility between January 6-10, 2020


BusinessToday.In
January 8, 2020
Share Market Update: BSE S&P Sensex closed 51 points lower at 40,817 and NSE Nifty50 ended 27 points lower at 12,025.


PB Jayakumar
December 30, 2019
The USFDA's Office of Manufacturing Quality (OMQ) at the Centre for Drug Evaluation Research (CDER) evaluates compliance with cGMP for drugs based on inspection reports and evidence gathered by USFDA investigators


PB Jayakumar
December 17, 2019
According to the report 'India: the emerging hub for biologics and biosimilars', the Indian pharmaceutical companies have launched 123 biosimilars and currently have 201 active biosimilars covering multiple indications in the development pipeline


PTI
November 18, 2019
The significant violations included failure to have adequate written procedures for the receipt, identification, testing and handling of raw materials


PB Jayakumar
New Delhi, November 7, 2019
Lupin's net sales for the quarter stood at Rs 4,296 crore, an increase of 10.4 per cent compared to Rs 3,890 crore in the Q2FY19. The company posted a net loss of Rs 127 crore (after exceptional items) in Q2FY20, compared to Rs 266 crore net profit during the same quarter of the previous year


PB Jayakumar
November 6, 2019
Most violations relate to rectifiable documentation, data maintenance, batch-wise consistent production quality, data on supply chain, stability issues, microbial contamination and quality checks


BusinessToday.In
November 5, 2019
After hitting intra day high of Rs 263.70, Biocon stock saw profit-booking and fell 3.11% to Rs 355 on BSE


PTI
October 25, 2019



PTI
New Delhi, October 13, 2019
Torrent Pharma recalls drugs from US, Puerto Rico: As per the report, Torrent Pharma Inc is recalling 17,088 bottles of Losartan Potassium /Hydrochlorothiazide tablets, USP 50mg/12.5mg from the same markets.


BusinessToday.In
September 30, 2019
Cipla share price fell to a fresh 52-week low after the company received 12 observations by USFDA for its manufacturing facility in Goa


PTI
August 20, 2019



Joe C Mathew
New Delhi, July 24, 2019
Kemwell will take a minority stake in Stempeutics and invest up to Rs 95 crore based on certain milestones as well as establish a world class cGMP cell therapy manufacturing  facility  at  Kemwell's  facility  in  Bengaluru.


Reuters
July 17, 2019
The U.S. Food and Drug Administration (FDA) said it found adulteration and \"significant violations\" of current good manufacturing practice (CGMP) regulations at Strides Pharma Sciences Ltd's plant in Puducherry in south India.


PTI
June 3, 2019



PTI
June 3, 2019



PTI
April 28, 2019



PTI
April 25, 2019



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