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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

Meanwhile, another recently released MHLW report confirmed that 696 essential drugs from 94 companies were identified as unprofitable due to increasing costs of manufacturing and packaging and the depreciation of the Japanese yen.

Marketing 173
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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

Meanwhile, another recently released MHLW report confirmed that 696 essential drugs from 94 companies were identified as unprofitable due to increasing costs of manufacturing and packaging and the depreciation of the Japanese yen.

Marketing 130
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Even Drugs Manufactured in America are not “Made in the USA”

Pharmacy Checkers

The Januvia package reads “Formulated in UK.” The Januvia package also states “Sitagliptin (active ingred.) the drug company that makes Janumet and Januvia) gets its sitagliptin from Italy to make Januvia, and it probably uses that same API to make Janumet. But Metformin is an off patent, widely-manufactured generic drug.

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A PSA on PSGs: PSG Meetings Are Now Available

FDA Law Blog

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 PSGs.

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Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

Importing medicines from countries that do not have our same strong standards could taint our medicine supply.”. The second sentence is deceptively broad: as in, yes, importing medicines from countries that do not have our “same” standards could taint our medicine supply. Not necessarily, but it could. If the U.S.

Drugs 71
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Drug labeling authority, UDI program reviewed by Harvard-based researchers

The Pharma Data

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. . Posted 17 May 2021 | By Jeff Craven .

Drugs 52
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Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

The FDA can prevent the importation of such drugs – but the agency is actually encouraged by law not to do so if the import is for personal use only. It’s also a story about consumers and their providers navigating conflicting public information about buying less expensive medicines online from foreign countries. Let’s call him John.