India invests to boost domestic API manufacture
In-PharmaTechnologist
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4y ago
Following API constraints due to the coronavirus, the Indian government takes measures to bolster domestic capabilities ..read more
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FDA lifts import alert on Ipca Labs for chloroquine supply
In-PharmaTechnologist
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4y ago
In order to boost the supply of chloroquine, the US FDA has allowed Ipca to supply APIs and finished product to the country ..read more
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The latest action by industry on COVID-19
In-PharmaTechnologist
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4y ago
A rundown of the latest updates emerging from industry in response to the developing coronavirus pandemic ..read more
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Once-monthly HIV regimen gets first regulatory approval
In-PharmaTechnologist
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4y ago
Health Canada marked the first positive nod to ViiV for its once-monthly HIV regimen, following rejection by the US FDA ..read more
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Generics manufacturer prioritizes cardiac drugs amid shortages fears
In-PharmaTechnologist
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4y ago
Medivant to prioritize manufacturing of four generic drugs for cardiac diseases, amid fears of drug shortages due to COVID-19 ..read more
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FDA halts domestic inspections, calls for industry to ‘own’ quality
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4y ago
The US FDA announces that it will no longer be able to carry out domestic facility inspections due to the risk posed by COVID-19 ..read more
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FDA approves migraine drug formulated for fast dispersion
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4y ago
Biohavenâs drug for acute treatment of migraine, manufactured using Catalentâs Zydis technology for orally disintegrating tablets, receives approval from the US FDA ..read more
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FDA and EMA provide timeline updates on action against coronavirus
In-PharmaTechnologist
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4y ago
Both the US FDA and EMA are updating timelines of steps taken to prevent the spread of the virus and to secure supply chains ..read more
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Warning letter cites shredded documents and faulty cameras in facility
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4y ago
Windlas issued a warning letter by the US FDA after the regulator finds the manufacturerâs response inadequate to justify wrongdoings at its India facility ..read more
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Industry ups chloroquine production, donates millions of doses
In-PharmaTechnologist
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4y ago
Manufacturers of hydroxychloroquine are increasing production and a number have offered to donate doses to combat COVID-19 ..read more
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