Chinese plant littered with rodent feces supplied OTC products to US; Recipharm acquisition spree continues

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Chinese plant littered with rodent feces supplied OTC products to US; Recipharm acquisition spree continues

In Phispers this week, we bring you news about US retailer Greenbrier International being issued an FDA warning letter for sourcing drugs from Chinese CMOs that were amongst the worst FDA rule offenders. In a first, the US drug regulator appro...
2019-11-21

https://www.pharmacompass.com/radio-compass-blog/chinese-plant-littered-with-rodent-feces-supplied-otc-products-to-us-recipharm-acquisition-spree-continues

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Mylan’s valsartan facility gets FDA warning letter; US sues Gilead over HIV drug patents

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Mylan’s valsartan facility gets FDA warning letter; US sues Gilead over HIV drug patents

This week, Phispers has news on Mylan’s valsartan facility in India receiving an FDA warning letter for nitrosamine contamination. The US government sued Gilead for infringing patents related to the HIV drug Truvada. While Strides Pharma re...
2019-11-14

https://www.pharmacompass.com/radio-compass-blog/mylan-s-valsartan-facility-gets-fda-warning-letter-us-sues-gilead-over-hiv-drug-patents

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Spanish API manufacturer cited for data-integrity violations; FDA recommends new system to rate quality of drugmakers

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Spanish API manufacturer cited for data-integrity violations; FDA recommends new system to rate quality of drugmakers

This week in Phispers, we bring you news on USFDA’s new report that recommends a new system to measure and rate the quality management maturity of drug manufacturing facilities. The drug regulator in Spain issued a statement of GMP non-compli...
2019-10-31

https://www.pharmacompass.com/radio-compass-blog/spanish-api-manufacturer-cited-for-data-integrity-violations-fda-recommends-new-system-to-rate-quality-of-drugmakers

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Sanofi pulls Zantac from US, Canada; FDA slams Chinese API manufacturer; DMF guidance update

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Sanofi pulls Zantac from US, Canada; FDA slams Chinese API manufacturer; DMF guidance update

This week, three drug distributors along with Teva, agreed with two Ohio counties to a US$ 260 million deal to avert the first federal trial over the opioid epidemic. In fact, this last-minute deal could open the door to a bigger US$ 48 billion set...
2019-10-24

https://www.pharmacompass.com/radio-compass-blog/sanofi-pulls-zantac-from-us-canada-fda-slams-chinese-api-manufacturer-dmf-guidance-update

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Former Ranbaxy promoters arrested; US plans tariffs on Swiss drug exports

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Former Ranbaxy promoters arrested; US plans tariffs on Swiss drug exports

This week, three drug distributors along with Teva, agreed with two Ohio counties to a US$ 260 million deal to avert the first federal trial over the opioid epidemic. In fact, this last-minute deal could open the door to a bigger US$ 48 billion set...
2019-10-17

https://www.pharmacompass.com/radio-compass-blog/former-ranbaxy-promoters-arrested-us-plans-tariffs-on-swiss-drug-exports

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Views: 1252
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FDA issues Form 483 to Cipla; warning letters to Torrent, Glenmark posted

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FDA issues Form 483 to Cipla; warning letters to Torrent, Glenmark posted

Indian drugmakers struggles with the US Food and Drug Administration (FDA) continue as every week there is news on regulatory action by the agency. Over the last fortnight, we have reported on the warning letter issued to Lupin’s Mandideep F...
2019-10-17

https://www.pharmacompass.com/radio-compass-blog/fda-issues-form-483-to-cipla-warning-letters-to-torrent-glenmark-posted

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Data-integrity concerns at Aurobindo; FDA issues warning letters to Glenmark, Torrent

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Data-integrity concerns at Aurobindo; FDA issues warning letters to Glenmark, Torrent

India’s leading generic drug manufacturers continue to be in the news for regulatory concerns regarding the state of their manufacturing compliance. Last week, after the US Food and Drug Administration (FDA) issued a warning letter to Lup...
2019-10-10

https://www.pharmacompass.com/radio-compass-blog/data-integrity-concerns-at-aurobindo-fda-issues-warning-letters-to-glenmark-torrent

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EMA pushes for review of all chemically synthesized APIs for nitrosamines; Trump’s order decries Pelosi’s drug policy

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EMA pushes for review of all chemically synthesized APIs for nitrosamines; Trump’s order decries Pelosi’s drug policy

This week, we update you on the ongoing Republicans versus Democrats slugfest in the US over their drug pricing policy plans. In a latest salvo, President Trump has decried the Democrats’ ‘Medicare-for-all’ proposal through an exe...
2019-10-10

https://www.pharmacompass.com/radio-compass-blog/ema-pushes-for-review-of-all-chemically-synthesized-apis-for-nitrosamines-trump-s-order-decries-pelosi-s-drug-policy

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Lupin’s FDA problems continue as Indian site receives warning letter; Takeda to offload OTC, prescription business

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Lupin’s FDA problems continue as Indian site receives warning letter; Takeda to offload OTC, prescription business

This week, Phispers brings you an update on Takeda’s efforts at reducing its debt burden, as it decides to sell assets in emerging markets and western Europe. Pfizer’s executive chairman Ian Read is stepping down by the year end, and Al...
2019-10-03

https://www.pharmacompass.com/radio-compass-blog/lupin-s-fda-problems-continue-as-indian-site-receives-warning-letter-takeda-to-offload-otc-prescription-business

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Views: 1811
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GSK, Dr. Reddy’s halt ranitidine supplies on carcinogen concerns; Democrats unveil drug pricing plan

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GSK, Dr. Reddy’s halt ranitidine supplies on carcinogen concerns; Democrats unveil drug pricing plan

This week, Phispers brings you news on the drug pricing package unveiled by Democrats in the US, which is similar to the HHS plan, known as the International Pricing Index. After concerns of a nitrosamine impurity in ranitidine, Sandoz recalle...
2019-09-26

https://www.pharmacompass.com/radio-compass-blog/gsk-dr-reddy-s-halt-ranitidine-supplies-on-carcinogen-concerns-democrats-unveil-drug-pricing-plan

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Views: 2036
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