Tag: USFDA

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» 2019-08-07

Cadila Healthcare today said that the US FDA has classified its Moraiya factory near Ahmedabad as ‘official action indicated’ or OAI. OAI is one of the three types of classification […]

» 2019-08-05

Pharma manufacturer Lupin said its Aurangabad factory has successfully obtained an Establishment Inspection Report (EIR) from the US FDA for its May inspection. The receipt of an EIR signifies the […]

» 2019-07-25

Caplin Point Laboratories said it has received an Establishment Inspection Report (EIR) from the US FDA for a recently concluded inspection at the manufacturing plan run by its unit Caplin […]

» 2019-06-20

Glenmark Pharmaceuticals said it received tentative approval from the United States Food & Drug Administration for a generic version of Mylan Pharma’s acne cream Evoclin. According to IQVIATM sales data, […]

» 2019-06-17

Pharmaceuticals maker Caplin Point Laboratories said the US FDA has completed inspection of its Sterile Injectable manufacturing facility at Gummidipoondi in Chennai and issued two observations. The good manufacturing process […]

» 2019-06-06

Hyderabad-based pharmaceutical company Natco Pharmaceuticals said United States Food and Drug Administration (USFDA) issued nine observations after an inspection at Natco’s formulation facility in Kothur, Hyderabad. Natco said it believes […]

» 2019-06-06

Pharmaceutical manufacturer Alembic Pharmaceuticals Ltd said it received approval from the United States Food and Drug Administration (USFDA) for the sales of a therapeutic equivalent of Merck Sharp & Dohme […]

» 2019-06-05

Mumbai-based pharmaceutical company Indoco Remedies said that the United States Food and Drug Administration (USFDA)  issued four observations after its inspection at Indoco’s sterile manufacturing facility in Verna, Goa. The […]

» 2019-06-03

Pharmaceutical manufacturer Zydus Cadila said that the United States Food and Drug Administration (USFDA) issued 11 observations after inspections at two of the manufacturing facilities of Nesher Pharmaceuticals, a subsidiary […]

» 2019-05-23

Pharmaceutical manufacturer Zydus Cadila said that it received final approval from the United States Food and Drug Administration (USFDA) for the sales of a generic equivalent of Nexium Delayed-Release capsules […]

» 2019-05-22

Pharmaceutical major Lupin said it launched the asthma drug Budesonide Inhalation Suspension ampules in the US market.   Budesonide Inhalation Suspension ampules are a generic equivalent of Pulmicort Respules Inhalation […]

» 2019-05-21

Alembic Pharmaceuticals Ltd said it received final approval from the United States Food and Drug Administration for the sales of a therapeutic equivalent of Vesicare tablets manufactured by Astellas Pharma […]

» 2019-05-15

Pharmaceutical firm Dr Reddy’s Laboratories Ltd said it has launched Daptomycin antibiotic in the US market. Daptomycin is used alone or in combination with other medications to treat certain blood […]

» 2019-05-14

Pharmaceutical major Lupin said that the United States Food and Drug Administration (USFDA) has given it an Establishment Inspection Report (EIR) for its Mumbai-based global  pharmacovigilance group, Drug Safety & […]

» 2019-05-14

Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the United States Food and Drug Administration (USFDA) for sales of a generic equivalent of AstraZeneca Pharmaceuticals’ Nexium-Delayed Release […]

» 2019-05-13

Pharmaceutical manufacturer Zydus Cadila said it received the final approval for sales of a generic equivalent of Pfizer’s Thalitone tablets. Chlorthalidone tablets are used for the treatment of high blood […]

» 2019-05-10

Pharmaceutical major Lupin announced the launch of a generic equivalent of Lundbeck Pharms’ Onfi tablets in the US market. Clobazam is used to control seizures in adults and children 2 […]

» 2019-05-07

Pharmaceutical major Lupin said that it received tentative approval from the United States Food and Drug Administration for the sales of a generic equivalent of Merck Sharp & Dohme Corp’s […]

» 2019-05-07

Pharmaceutical company Unichem Laboratories said it received a tentative approval from the United States Food and Drug Administration (USFDA) to sell a generic equivalent of Johnson and Johnson Consumer Inc’s […]

» 2019-05-06

Alembic Pharmaceuticals said one of its dermatology-focused joint ventures, Aleor Dermaceuticals Ltd, received an Inspection Report for its formulation facility at Karakhadi, Gujarat from the United States Food and Drug […]

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