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Tag: usfda

You Searched For "usfda"
Alembic Pharma gets USFDA Final nod for Doxycycline Hyclate Tablets

Alembic Pharma gets USFDA Final nod for Doxycycline Hyclate Tablets

Ruchika Sharma15 May 2020 3:29 PM IST
Vadodara: Alembic Pharmaceuticals Limited has announced it has received approval from the US Food & Drug Administration (USFDA) for its...
Alkem Labs gets USFDA EIR for St Louis facility in US

Alkem Labs gets USFDA EIR for St Louis facility in US

Ruchika Sharma15 May 2020 11:13 AM IST
New Delhi: Drug firm Alkem Laboratories on Tuesday said the US health regulator has issued an establishment inspection report (EIR) for its St Louis...
Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension

Lupin receives USFDA EIR for Vizag API Facility

Ruchika Sharma14 May 2020 4:19 PM IST
Mumbai: Lupin Limited has announced the receipt of the Establishment Inspection Report (EIR) from the United States Food and Drug Administration...
Dr Reddys Labs gets USFDA EIR for Srikakulam formulations plant

Dr Reddy's Labs gets USFDA EIR for Srikakulam formulations plant

Ruchika Sharma14 May 2020 11:38 AM IST
Hyderabad: Dr. Reddy's Laboratories Ltd on Wednesday said it has received an Establishment Inspection Report (EIR) from the US Food and Drug...
Ind-Swift Labs gets USFDA EIR for Derabassi API facility

Ind-Swift Labs gets USFDA EIR for Derabassi API facility

Ruchika Sharma12 May 2020 1:23 PM IST
Mumbai: Ind-Swift Laboratories Limited has received the Establishment Inspection Report (EIR) from the USFDA, for the Surveillance GMP inspection of...
Dr Reddys recalls 1,752 bottles of  Esomeprazole Magnesium delayed-release capsules in US

Dr Reddy's recalls 1,752 bottles of Esomeprazole Magnesium delayed-release capsules in US

Ruchika Sharma11 May 2020 2:46 PM IST
The ongoing Class III recall is on account of "Discolouration" and because the product contains brown pellets, USFDA said
Pfizer to focus on coronavirus vaccine; outsource some drug production

Pfizer to focus on coronavirus vaccine; outsource some drug production

Ruchika Sharma11 May 2020 2:28 PM IST
If successful, Pfizer said it hopes to receive emergency use authorization from the USFood and Drug Administration as early as October
Dr Reddys Labs gets USFDA inspection closure report for Srikakulam plant

Dr Reddy's Labs gets USFDA inspection closure report for Srikakulam plant

Ruchika Sharma11 May 2020 12:42 PM IST
New Delhi: Drug major Dr. Reddy''s Laboratories on Friday said the US health regulator has closed inspection of its manufacturing facility in...
USFDA extends action date for Bristol Myers Squibb Lisocabtagene Maraleucel (liso-cel)

USFDA extends action date for Bristol Myers Squibb Lisocabtagene Maraleucel (liso-cel)

Ruchika Sharma10 May 2020 12:15 PM IST
Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19
Cipla gets USFDA EIR for Bommasandra API facility

Cipla gets USFDA EIR for Bommasandra API facility

Ruchika Sharma10 May 2020 10:00 AM IST
Bangalore: Cipla has announced that it has received Establishment Inspection Report (EIR) from USFDA for its API manufacturing facility in...
Neuland Labs gets USFDA EIR for Pashamylaram Manufacturing Facility

Neuland Labs gets USFDA EIR for Pashamylaram Manufacturing Facility

Ruchika Sharma9 May 2020 11:52 AM IST
Hyderabad: Neuland Labs has received an Establishment Inspection Report (EIR) from the U.S.FDA for its manufacturing facility located at Pashamylaram,...
Biocon gets EIR for Small Molecules API Manufacturing Facility for Pre -Approval, GMP USFDA Inspection

Biocon gets EIR for Small Molecules API Manufacturing Facility for Pre -Approval, GMP USFDA Inspection

Ruchika Sharma8 May 2020 2:29 PM IST
Bengaluru: Biocon has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the Pre-Approval and GMP...
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