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Articles for Regulatory

Granules India Gets USFDA Nod For OTC Equivalent Of Advil Dual Action Tablets

Acetaminophen and Ibuprofen Tablets are used for temporary relief for minor aches and pains due to: headaches, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis

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FDA Clears First OTC Birth Control Pill In US

The approval comes as more states ban abortion following a ruling by the Supreme Court last year that overturned the Roe v. Wade decision to legalize the procedure nationwide

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USFDA Inspects Lupin’s Nagpur Oral Drug Facility Issues Form 483, Two Observations

On Wednesday Lupin, the Indian pharmaceutical major based in Mumbai stated in an exchange filing that USFDA inspected its Nagpur Oral Solid Dosage Facility from July 3 to July 11, 2023

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Multivalent Meningococcal Meningitis Vaccine From Serum Institute of India Gets WHO Prequalification

Meningococcal meningitis is a bacterial infection that sets in rapidly and can kill within hours. It can cause severe brain damage and sepsis leading to limb amputation and is fatal in 50 percent of cases if untreated

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USFDA Calls Recall Of J&J's Electrosurgical Tools As Most Serious

The U.S. health regulator said it had received reports of pediatric and adult patients suffering burn injuries when the tools, sold under the brand names MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes, were used on them

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Lupin Gets Green Flag From USFDA For Its Pithampur Unit-2 Facility

Global pharma major Lupin on Tuesday said in an exchange filing that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Pithampur Unit-2 manufacturing facility that manufactures oral solids and ophthalmic dosage forms

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Health Minister Directs DCGI To Punish Firms Making Spurious Drugs

Mandaviya has directed the Drugs Controller General of India (DCGI) to take stringent action against all pharmaceutical manufacturing companies that make spurious drugs. “There shall be no compromise with the quality of drugs manufactured in India”, he emphasised

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USFDA Clears Sarepta's Gene Therapy For Rare Muscular Dystrophy In Some Kids

Sarepta said on Thursday the Food and Drug Administration had approved the treatment for children aged between 4 and 5 years who can walk. It was initially seeking approval for all DMD patients who can walk

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