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Roquette unveils refreshed coatings platform for pharma and nutra markets

Express Pharma

billion by 2027, driven by increasing demand for innovative patient-friendly dosage forms, said Paul Smaltz, Head of the Pharmaceutical Solutions Business Unit at Roquette. The platform provides manufacturers with ready-to-use coating premixes for pharmaceutical prescription, nutraceutical, and over-the-counter (OTC) products.

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17th edition of CPHI & PMEC India inaugurated at India Expo Centre, Noida

Express Pharma

.” Dr Veeramani, Chairman, Pharmexcil, said “ The Indian pharmaceutical industry stands as a global leader, exporting to over 200 countries and providing comprehensive solutions across APIs, finished dosages, clinical research, and pharmacovigilance. Adam Anderson , Executive VP – Pharma, Informa Markets B.V

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Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

AbbVie anticipates Rinvoq sales to exceed $7.5bn in 2025 and for the peak revenues from both drugs to exceed Humira’s peak sales by 2027. The FDA has recommended that patients start with 45mg Rinvoq once daily for 12 weeks, with a maintenance dosage of 15mg following the 12-week period.

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Personalized Medicine Requires a New Approach to Quality Control

Syner-G

It guarantees delivery of the right drug and the right dosage at precisely the right time , tailored specifically for that person. Cell and gene therapies have been subjects of research for some time, but they have gained traction in real-world medicine and are projected to reach a market value of more than $36 billion by 2027.

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MAPPing a New Route: FDA Updates MAPP on Suitability Petitions

FDA Law Blog: Biosimilars

Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient. Under 21 C.F.R.

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Top Performing Drug of 2021 - Trulicity (February Edition)

PharmaShots

Active Ingredient: dulaglutide Dosage Forms & Strengths: Injection: 0.75 In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026). mL, 3 mg/0.5 Hence, it needs to protect its patent as Trulicity patents are very vital to the company’s business as a whole.

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AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

FDA Law Blog: Biosimilars

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs.

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