USFDA Archives

Alidac Pharmaceuticals receives zero observations from USFDA

adminJune 6, 2018

June 6, 2018

Alidac Pharmaceuticals, the wholly-owned subsidiary of Zydus Cadila has received zero observations, from the US health regulator. The US health regulator had conducted an inspection of its manufacturing...

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Unichem Laboratories receives EIR for Ghaziabad unit from USFDA

adminJune 5, 2018

June 5, 2018

Unichem Laboratories has received establishment inspection report (EIR), from the US health regulator. The company’s formulation manufacturing facility at Ghaziabad has received an EIR, from USFDA. The...

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Cadila gets USFDA nod for Doxycycline Hyclate capsules

adminJune 4, 2018

June 4, 2018

Zydus Cadila has received final approval to market Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, from the USFDA. It is a tetracycline antibiotic which is...

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Zydus Cadila gets USFDA approval to market Nystatin ointment

adminMay 28, 2018

May 28, 2018

Zydus Cadila receives final approval to market Nystatin ointment and Omeprazoleand Sodium Bicarbonate capsule, from the US health regulator. The company received approval to market Nystatin Ointment USP,...

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Cadila gets USFDA approval to market drug for prostate condition

adminMay 25, 2018

May 25, 2018

Zydus Cadila has received final approval from the US health regulator to market Dutasteride and Tamsulosin Hydrochloride capsules. It is used to treat symptoms of Benign...

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Sun Pharma gets USFDA approval for YONSA

adminMay 23, 2018

May 23, 2018

Sun Pharmaceuticals has received the USFDA approval for a drug named YONSA. YONSA is a novel formulation in combination with methylprednisolone, for the treatment of...

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Glenmark Pharma submits drug application for Ryaltris with USFDA

adminMay 22, 2018

May 22, 2018

Glenmark Pharmaceuticals has submitted a new drug application for its nasal spray Ryaltris, with the US health regulator. In a BSE filing the company stated,...

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Glenmark gets USFDA approval for Colesevelam Hydrochloride tablets

adminMay 21, 2018

May 21, 2018

Glenmark Pharma has received final approval for Colesevelam Hydrochloride tablets, 625 mg, the generic version of Daiichi Sankyo’s Welchol tablets, 625 mg, from the US...

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USFDA completes inspection of Indoco Remedies, Navi Mumbai facilities

adminMay 21, 2018

May 21, 2018

The USFDA has completed the inspection of Indoco Remedies, API manufacturing facilities at Patalganga and Rabale, Navi Mumbai. In a release the company stated that, the inspection...

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Granules India receives USFDA nod for Methylergonovine tablets

adminMay 17, 2018

May 17, 2018

Granules India has received USFDA’s approval for Methylergonovine 0.2 mg tablets. The abbreviated new drug applications (ANDA) was filed by Granules Pharmaceuticals Inc., a wholly...

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Tag : USFDA

Alidac Pharmaceuticals receives zero observations from USFDA

Unichem Laboratories receives EIR for Ghaziabad unit from USFDA

Cadila gets USFDA nod for Doxycycline Hyclate capsules

Zydus Cadila gets USFDA approval to market Nystatin ointment

Cadila gets USFDA approval to market drug for prostate condition

Sun Pharma gets USFDA approval for YONSA

Glenmark Pharma submits drug application for Ryaltris with USFDA

Glenmark gets USFDA approval for Colesevelam Hydrochloride tablets

USFDA completes inspection of Indoco Remedies, Navi Mumbai facilities

Granules India receives USFDA nod for Methylergonovine tablets

EquityPandit