Dr Reddy’s gets four observations from USFDA for Srikakulam plant
The audit of the company's API Srikakulam Plant (SEZ) was completed last week
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Browsing Tag
United States Food and Drug Administration
Torrent Pharma gets warning letter from US FDA for Gujarat facility
The company is committed in maintaining the highest standards of compliances and quality manufacturing across all its facilities…
Dr Reddy’s launches heartburn capsules in US market
The capsules are used for the treatment of frequent heartburn in the US market
The company has launched Lansoprazole…
Lupin receives US FDA approval for Fosaprepitant Injection
The drug is indicated for the prevention of acute and delayed nausea and vomiting
Lupin has received approval for its…
Indoco’s CRO – AnaCipher clears US FDA inspection with ZERO 483
The inspection successfully concluded without any observations and no form 483 is issued
Indoco Remedies gets warning letter from USFDA for oral dosages plant in Goa
The company has received a warning letter from the United States Food and Drug Administration (USFDA) as a result of the…
US FDA issues 5 observations to Dr Reddy’s plant in Hyderabad
The company has been issued a Form 483
Dr Reddy's Laboratories said the US health regulator has issued five observations after…
Glenmark Pharmaceuticals receives ANDA approval for Ranolazine
Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg are a generic version of Ranexa Extended-Release Tablets, 500 mg and…
Strides Pharma Puducherry unit receives warning letter from US FDA
The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator
Glenmark receives ANDA approval for norethindrone acetate and ethinyl estradiol tabs
The tablets are indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of…