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FDA DRUG INSPECTION
Punjab drug body finds critical lapses at Jackson Laboratories' manufacturing facility in AmritsarThe Punjab FDA has taken decisive action by revoking the manufacturing licence of Jackson Laboratories in Amritsar due to severe regulatory...
Maharashtra FDA bans serving food in newspapers, issues statewide food safety orderMaharashtra FDA has launched 'Safe Food, Healthy Maharashtra' banning food served on newspapers and enforcing strict hygiene. Hotels, resta...
Plan in the works to let hospitals import med equipment directlyIndia's drug regulator is proposing to allow hospitals to directly import advanced medical equipment like MRI and CT scanners, bypassing cu...
USFDA concludes inspection at Jubilant HollisterStier's Spokane plant with 8 observationsJubilant Pharmova announced its US subsidiary, Jubilant HollisterStier LLC, underwent a USFDA inspection. The facility in Spokane, Washingt...
Maharashtra FDA bars hospitals from forcing patients to buy medicines in-houseMaharashtra's Food and Drug Administration has issued a significant directive. Hospitals and medical practitioners must now allow patients ...
Dabur India shares in focus after US FDA places drugs from Silvassa plant under import alert. Here’s whyDabur India shares are set to be in focus after the US FDA issued an import alert on drugs manufactured at its Silvassa plant, citing data ...
US drug regulator issues import alert for drugs made at a Dabur India plantThe US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection that revealed si...
More macro headwinds on the cards? Tackle them with core principles: 6 pharma stocks with upside potential of up to 28%There was a time when the Indian pharma story in the US was almost entirely about inspection risk. The US FDA would inspect a plant, a warn...
U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plantThe U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Find...
No 'zombie drug', man seen in Thane video overdosed on pain medicine: PoliceThane police have clarified a viral video showing a disoriented man. The man was not under the influence of a 'zombie drug'. He had taken a...
US Senator raises alarm over poor-quality drug imports from India and China, seeks tougher FDA inspectionsIn a letter to FDA Commissioner Martin Makary, Banks said the agency must "do more to protect the US drug supply," warning that lax oversig...
US lawmakers questions FDAs drug inspection programme in India and ChinaThree top American lawmakers have raised concerns about the FDA's foreign drug inspection program in India and China. In a letter to FDA Co...
Understanding US FDA inspection: How investors and management can avoid heartburnWith India playing a significant role in the global pharmaceutical sector, one may wonder about the quality control practices adopted in th...
Indian pharma compliance standards improving, regulatory risks here to stay: Ind-RaAs Indian pharma accounts a significant share of the US generic market, Ind-Ra said it has seen increased scrutiny of the manufacturing fac...
US senator seeks unannounced inspections of foreign drug manufacturing units in India and ChinaThe chairman of the Senate Finance Committee said this was needed as these facilities provided most of the ingredients for production insid...
- Drug cos eye US entry after FDA checks
The US drug regulator has inspected the manufacturing plants of at least half-a-dozen Indian drugmakers, raising hopes that these companies...
- US FDA inspects Lupin's new plant in Indore
The US drug regulator has started inspection of Indian drugmaker Lupin’s upcoming plant at Indore last week, a person close to the developm...
- Ranbaxy asks US FDA to re-inspect Dewas facility
India’s largest drugmaker Ranbaxy has invited the US drug regulator to re-inspect its manufacturing plant at Dewas, raising hopes of an ear...
- USFDA clears Cipla's facilities
Cipla has successfully addressed all the nine manufacturing deficiencies pointed out by the US Food and Drug Administration (FDA) at its Ba...
- Lupin’s MP plant under USFDA scanner
The US Food and Drug Administration (USFDA) has found 15 manufacturing deficiencies at one of Lupin’s plant in Madhya Pradesh (MP) during t...