Lupin and Aurobindo Pharma initiates nationwide recall
Pharma News – 20 February: The latest enforcement report of the USFDA has led to the recall of certain medications by two major pharma companies. The companies involved are Lupin and Aurobindo Pharma.
Baltimore – based unit of Lupin Pharmaceuticals Inc. has been actively recalling an antiviral medication. This medication is called Oseltamivir Phosphate for Oral suspension and over 46,479 bottles are being recalled. The Hyderabad – based drug maker, Aurobindo Pharma, is also undertaking similar measures to recall Acetaminophen injection. Read more: Lupin and Aurobindo Pharma Recall certain medications
USFDA approves Lupin’s Posaconazole tablets
On 17 February 2021, Lupin Limited announced the launch of Posaconazole delayed–release tablets in the United States. This tablet is marketed at the dose of 100 mg. This delayed–release tablet is the generic equivalent of Noxafil Delayed-release tablets, 100 mg. The latter is manufactured by Merck Sharp & Dohme Corp. Read more: USFDA approves Lupin’s Posaconazole tablets
GMP Violation by Alembic Pharma
Pharma News – 20 February: At the beginning of February 2021, the US drug regulator issued “Form 483” to the Kharkhadi unit of Alembic Pharma. This is a sterile injectables manufacturing unit of the drug firm that is situated in Gujarat. The violations were related to quality control, cleanliness and size of the equipment, and inadequate sample collection procedures at the site. Read more GMP Violation by Alembic Pharma
The BioNTech / Pfizer COVID – 19 vaccines can be stored at – 25 to – 15 degrees Celsius for up to two weeks
On 19 February 2021, Pfizer announced that its COVID -19 vaccine could withstand warmer temperatures in pharmaceutical freezers and refrigerators. This jab can now be stored for up to 2 weeks at – 25 to – 15 degrees Celsius ( – 13 to 5 degrees Fahrenheit ). The company has contacted the USFDA to seek this storage temperature approval. Know about The BioNTech/Pfizer COVID vaccines
5. Effectiveness of AstraZeneca’s COVID – 19 vaccine increases with a 3 months gap before the second dose :
Pharma News – 20 February: AstraZeneca and Oxford have claimed that their vaccine was more effective with a 3-month gap before the second dose. This was revealed in a peer–reviewed study in a medical journal (The Lancet on 19 February 2021).
The World Health Organization has also approved this vaccine for emergency use in the third week of February 2021. This, in turn, has paved the way for the distribution of this vaccine to developing countries through the COVAX program. Read more: AstraZeneca’s COVID–19 vaccine