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STAT+: Generics companies fought to stop the new drug pricing law. But they may end up benefiting

STAT

WASHINGTON — Generic drugmakers lobbied hard against Democrats’ new law empowering Medicare to negotiate prescription drug prices. Giving the government such power seemed like an admission that generic medicines don’t do enough to keep costs down.

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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

This is due to the regulatory requirements imposed on parallel imported medicinal products in various Member States, the fulfilment of which often requires repackaging. Repackaging a medicinal product… means that the trademark is reapplied by an entity other than the trademark proprietor.”

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IPA questions FAERS data interpretation in the Ohio State University study

Express Pharma

It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database. The FDA has an established office in India overseeing the number of qualified manufacturers supplying generic medicines to the US.

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Mankind Pharma launches 120 DMF quality drugs for Indian patients

Express Pharma

The Drug Master File (DMF) has all the information on an API (Active Pharmaceutical Ingredient/Raw material for medicine) Mankind Pharma has introduced 120 DMF (Drug Master File) Quality Medicines in the Indian market. This initiative aims to ensure universal access to medicines of international calibre.

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What happened to all the antibiotics?

pharmaphorum

These include allowing the exceptional supply of certain medicines that may not be authorised in a particular Member State or granting full or partial exemptions to certain labelling and packaging requirements to address severe problems in respect of the availability of some medicines.”

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Event Summary – Masterclass: International Pharma Marketing by Shailesh Kapadia

PharmaState Academy

Discussions also covered the hierarchy in international marketing, expected packages, responsibilities, and territories of medical representatives and country managers. He highlighted potential opportunities due to the low cost of skilled labor, expanding market size, and increasing global demand for generic drugs.

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Halting Europe’s essential medicines manufacturing exodus

European Pharmaceutical Review

The recent update to the EC Urban Waste Directive, part of the environment package ‘Towards Zero Pollution,’ 4 has a disproportionate producer responsibility principle that will incur considerable extra costs. This is likely to make some essential medicines and APIs economically unsustainable to manufacture.