Tag: USFDA

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» 2019-04-18

Pharmaceutical manufacturer Granules India Ltd said that it has received approval from the United States Food and Drug Administration to sell a bioequivalent version of Johnson & Johnson’s Tylenol tablets. […]

» 2019-04-12

Pharmaceutical major Lupin said that it has launched a generic equivalent of AbbVie Inc’s AndroGel, a a day after it received approval for its sales from the United States Food […]

» 2019-04-11

Pharmaceutical major Lupin said that it has received approval from  the United States Food and Drug Administration for the sales of a generic equivalent of AbbVie Inc’s AndroGel. Testosterone Gel […]

» 2019-04-10

Pharmaceutical major Lupin said that it launched a generic equivalent of Alvogen Group Holdings’ psychiatric drug Fluoxetine. Fluoxetine tablets sold in 60 mg dose had annual sales of $41 million […]

» 2019-04-08

Indian pharmaceutical manufacturer Caplin Point Laboratories said that its  wholly-owned subsidiary Caplin Sterlites Ltd signed a licence and supply agreement with US healthcare firm Baxter International for sales of five […]

» 2019-04-08

Pharmaceutical manufacturer Zydus Cadila said that it received tentative approval from the US Food and Drug Administration for sales of a generic equivalent of UCB Inc’s Vimpat tablets. A tentative […]

» 2019-04-03

Pharma major Lupin said that the inspection of the US Food and Drug Administration (USFDA) at its bioresearch facility in Pune has concluded without any observation. Conclusion of an inspection […]

» 2019-04-02

Pharmaceutical manufacturer Zydus Cadila said that it has received tentative approval from the US Food and Drug Administration for sales of mirabegron extended-release tablets. A tentative approval means that the […]

» 2019-04-02

Pharma major Lupin said that the United States Food and Drug Administration has given it an Establishment Inspection Report (EIR) for its Pithampur facility, which was slapped with five observations […]

» 2019-04-02

Pharmaceutical Strides Pharma Science Ltd said wholly owned subsidiary Vensun Pharmaceuticals and partner Pharmaceutics International received approval from the United States Food and Drug Administration to launch a generic equivalent […]

» 2019-04-02

Pharmaceutical major Lupin said that it has launched the generic equivalent of Eli Lilly’s Cialis erectile dysfunction tablets. Lupin had received the approval from the United States Food and Drug […]

» 2019-03-29

Pharmaceutical manufacturer Zydus Cadila said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of Gilead Sciences’ hypertension drug […]

» 2019-03-27

Indian pharmaceutical manufacturers Lupin, Unichem Laboratories and Alembic Pharmaceuticals said that they has received approval from the United States Food and Drug Administration to sell generic versions of Eli Lilly’s […]

» 2019-03-27

Pharmaceutical major Strides Pharma Science Ltd said it received approval from the United States  Food and Administration for its greenfield oral medication facility in Singapore, giving a boost to the […]

» 2019-03-25

Pharmaceutical major Lupin said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of Pfizer Inc’s Viagra tablets. Sildenafil […]

» 2019-03-22

Pharmaceutical manufacturer Zydus Cadila said it received final approval from the United States Food and Drug Administration for sales of a generic version of Sunovion Pharmaceuticals’ Latuda tablets. Lurasidone tablets […]

» 2019-03-22

Pharmaceutical manufacturer Caplin Point Laboratories Ltd said it received approval from the US Food and Drug Administration for sales of a generic equivalent of West-Ward Pharmaceuticals’ Robinul drug. Glycopyrrolate is […]

» 2019-03-22

Gujarat-headquartered Alembic Pharmaceuticals said that it received approval from the United States Food and Drug Administration for sales of a generic version of Mylan’s Optivar eye-drops. Azelastine Hydrochloride Solution eye […]

» 2019-03-15

Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the US Food and Administration (USFDA) for the sale of a generic version of Valeant Bermuda’s acne treatment, BenzaClin. […]

» 2019-03-14

Pharmaceutical manufacturer Zydus Cadila said it received tentative approval from the US Food and Administration for the sales of of Sitagliptin and Metformin oral diabetes tablets that help control blood […]

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