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Lipidor signs cooperation agreement with contract manufacturer to offer licensees the opportunity for GMP production

The Pharma Data

Lipidor has already cooperated with the contract manufacturer Aurena Laboratories regarding hand and skin disinfection sprays and veterinary care products. This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). Certified Adviser.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

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HPAPIs – Current Interest of the Pharmaceutical Industry

Roots Analysis

Corticosteroids are produced by adrenal gland and play a role in controlling stress to decrease inflammation whereas, anabolic steroids regulate the manufacturing of testosterone in the testicles and the ovaries. This is in contrast to the containment requirements at manufacturing facilities of traditional APIs.

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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Novartis signs new initial agreement with BioNTech to support fill and finish of the mRNA Pfizer-BioNTech COVID-19 vaccine

The Pharma Data

Pfizer-BioNTech COVID-19 vaccine; or regarding implicit unborn earnings from the contract manufacturing agreement with BioNTech for the Pfizer-BioNTech COVID-19 vaccine. There can be no guarantee that our manufacturing of the the Pfizer-BioNTech COVID-19 vaccine will be successful.

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Therma Bright Acquires 100% Control of its COVID-19 Rapid Saliva Antigen Test and Announces Proposed Name Change for the Test

The Pharma Data

Therma Bright is also in the process of identifying component suppliers to be used in the large-scale manufacturing of the SCV2 test and is identifying contract manufacturers to manufacture and assemble the final product.

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Russia’s focus on domestic pharma production could shield it from sanctions’ effects

Pharmaceutical Technology

Russia is an already insular country and its worldview has tended to be self-contained, but this has hardened in the face of recent sanctions and counter-sanctions imposed during the war with Ukraine. AbbVie (North Chicago, Illinois) and Novartis (Basel, Switzerland) have also withdrawn from their businesses in Russia.