Most of the observations relate to deficiencies in maintaining equipment, cleanliness of equipment and utensils, sterility, employees training, lab controls and computer controls
Unit IV observations are milder than expected and has low chance of escalation, Credit Suisse said.
USFDA issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.
The U.S. Food and Drug Administration (FDA) said late on Friday it had granted approval for expanded use of Imfinzi to treat non-small cell lung cancer (NSCLC) patients with inoperable mid-stage disease that has not spread widely around the body.
The company has received final approval to market its generic Clobetasol Propionate cream USP, 0.05 per cent, from the United States Food and Drug Administration (USFDA), Lupin said in a statement.
Cipla in a BSE filing said it has received final approval from the United States Food and Drug Administration (USFDA) for tenofovir disoproxil fumarate tablets, 300 mg.
The move is aimed at ensuring youngsters do not get addicted to tobacco products, a top Food and Drug Administration (FDA) official said.
The sleekly packaged little tube would not look out of place in an Apple store. It is designed to heat tobacco but not burn it. Most of the harmful chemicals in tobacco are released when tobacco is burned.
As per the US health regulator's enforcement report for the week of January 17, a single lot of 1,051 vials of Docetaxel injection USP, 20 mg/mL was distributed in the US, Uzbekistan and Myanmar. The company has recalled the drug on account of defective container, the report said.
The FDA had reportedly conducted a "surprise check" on the McDonald's outlet in High Street Phoenix at Lower Parel for alleged violation of the Food Safety Standards Act, by cooking in unhygienic conditions, and also not displaying its licence copy prominently.
Biosimilar trastuzumab, indicated for breast cancer treatment, has been co-developed by Biocon and Mylan.
The company has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 25 mg, 50 mg and 75 mg, Zydus Cadila said in a BSE filing.
Pharmaceutical major Lupin Ltd gets USFDA nod for a generic psoriasis treatment solution.
The approval by US Food & Drug Administration (USFDA) is for multiple strengths of Fondaparinux Sodium injection of 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL, and 10 mg/0.8 mL single-dose prefilled syringes, the company said in a statement.
"Glenmark Pharmaceuticals USA has been granted final approval by the US Food and Drug Administration (USFDA) for Norethindrone Acetate and Ethinyl Estradiol tablets USP and Ferrous Fumarate tablets, 1 mg/20 mcg, the generic version of Minastrin 24 Fe tablets," the company said in a BSE filing.
"The US Food and Drug Administration (USFDA) has accepted a new drug application (NDA), filed by its wholly owned subsidiary, for OTX-101 (cyclosporine A, ophthalmic solution)," Sun Pharmaceutical Industries said in a BSE filing.
The drug, which is used to treat certain types of cancer, was earlier approved by the US Food and Drug Administration (USFDA), DRL said in a statement.
The US Food and Drug Administration (USFDA) has granted orphan drug designation for Tenalisib (RP6530)... for the treatment of patients with peripheral T-cell lymphoma (PTCL), Alembic Pharmaceuticals said in a BSE filing.
The company has received the approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 30mg, 60mg and 90 mg, Zydus Cadila said in a BSE filing.
"The US Food and Drug Administration (USFDA) has cleared Montelukast Sodium, a bulk drug/API manufactured by Morepen Laboratories, for sale in the US market," the company said in a regulatory filing.
The settlement was disclosed in documents filed in federal court in Trenton, New Jersey, over a year after the U.S. Consumer Product Safety Commission voted to refer a case involving the drugmaker to the U.S. Justice Department.
In a filing to BSE, the company said it "has received ANDA (abbreviated new drug application) approval from USFDA (United States Food and Drug Administration) for Aripiprazole Orally-Disintegrating tablets USP, 10 mg and 15 mg."
"The United States Food and Drug Administration (USFDA) has approved the company's supplementary Abbreviated New Drug Application (ANDA) for Atenolol tablets USP 25mg, 50mg and 100 mg," J B Chemicals & Pharmaceuticals said in a BSE filing today.
The approval was granted for Darifenacin extended release tablets for the treatment of an overactive bladder.
The company yesterday said it has received an EIR from USFDA on December 11 as closure of audit for its formulations manufacturing plant - 3 at Bachupally, Hyderabad. Dr Reddy's was issued a form 483 with 11 observations.