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Complete response letter given to ALS treatment for API concern
The FDA has handed a CRL to Biohaven for its ALS treatment awaiting approval due to concerns regarding the medication’s API.
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Active Pharmaceutical Ingredient (API)
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Macleods Pharmaceuticals issues recall due to NMBA impurities
Macleods has issued a recall of 32 lots of drug products that contained trace amounts of NMBA impurities.
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Whitepaper: Influence of different lubricants on tabletting characteristics and dissolution behaviour
Lubricants have a far more wide-reaching impact on the characteristics of the finished tablet than merely easing their means of production. A study was carried out to investigate precisely what those effects were.
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API markets to grow 6.8 percent by 2026
Global active pharmaceutical ingredients market set to surpass US$274.9 billion by 2026.
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Flyer: API Development Services
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long term API technology development needs.
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Whitepaper: VIVAPUR® MCG – a powerful stabiliser for nasal sprays
JRS Pharma present VIVAPUR MCG and outline the benefits of its formulation for application in nasal sprays.
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Nelson Labs: supporting internal quality processes
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…
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Taking the difficulty out of API process filtration
Amazon Filters has selected the Making Pharmaceuticals Exhibition & Conference 2019 to showcase its latest filter housings and microfiltration filter cartridges, which are used in the manufacture of Active Pharmaceutical Ingredients (API) and are the essential components when creating pharmaceutical products.
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Formulation In-Depth Focus 2019
As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
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Flyer: API commercialisation
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long-term API technology development and commercialisation needs.
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Heart drugs free from carcinogens identified as recalls drag on
The Food and Drug Administration has released a list of 40 drugs used to treat hypertension and heart failure that don’t contain any known carcinogens...
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Whitepaper: The performance of PROSOLV® EASYtab SP in four medium-dose
In the present study, the performance of PROSOLV® EASYtab SP was tested in four DC formulations with different model APIs. Each of the selected APIs presented a particular challenge in terms of producing tablets with suitable hardness, weight, uniformity, content uniformity and/or reliable dissolution profiles.
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CPhI North America: FPS confirm their presence for 2019
FPS Food and Pharma Systems is a leading company in the pharmaceutical and fine chemical fields, developing, manufacturing and installing worldwide its own range of fine size reduction machines and containment solutions (sterile and highly toxic API)...
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New generic valsartan approved to address shortages
The FDA has prioritised the review of this drug application after multiple recalls of generic valsartan products from several manufacturers...
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Aseptic containment strategies to meet challenges of processing new highly toxic and biologically hazardous sterile medicinal products and therapies
Active pharmaceutical ingredients (APIs) have been established in the pharmaceutical industry over the course of many years. Containment technologies – ie, those strategies developed to contain the APIs – and qualification practices based on API powder containment have primarily been based on health and safety issues related to operator exposure…
