Mfg News: Viatris, Lupin & AlembicBy
A roundup of manufacturing news from Viatris, Lupin, and Alembic Pharmaceuticals. Highlights below.
* Viatris Recalls One Lot of Injectable Drug Octreotide Acetate
* FDA Cites Lupin’s Biomanufacturing Facility
* FDA Cites Alembic’s Drug-Product Mfg Plant
Viatris Recalls One Lot of Injectable Drug Octreotide Acetate
Viatris is voluntarily recalling a single lot of octreotide acetate injection (500 mcg/mL, packaged in a carton of ten 1-mL syringes) at the user (hospital/pharmacy) level due to a product complaint of the presence of glass particles in a syringe.
The lot was manufactured by Italfarmaco SpA, a Milan, Italy-based pharmaceutical company and CDMO of drug products, and was distributed by Mylan Institutional, a Viatris company, in the US between January 11, 2022 and June 21, 2022.
Octreotide acetate injection is indicated to reduce blood levels of growth hormone and insulin growth factor-1 in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. It is also indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits severe diarrhea and flushing episodes associated with the disease and for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide-secreting tumors.
To date (October 25, 2022), Viatris says that no reports of adverse reactions associated with the lot have been received.
FDA Cites Lupin’s Biomanufacturing Facility
The US Food and Drug Administration has issued Lupin, a Mumbai, India-headquartered bio/pharmaceutical company, a Form 483 with 17 observations following a pre-approval inspection at the company’s biomanufacturing facility in Pune, India. The inspection took place in October 2022.
The company says that it will address the observations, and that it does not believe that the Form 483 will have an impact on the existing revenues from operations of the facility.
FDA Cites Alembic’s Drug-Product Mfg Plant
The US Food and Drug Administration (FDA) has issued a Form 483 with four procedural observations to Alembic Pharmaceuticals, a Vadodara, Gujarat, India-headquartered generics company and manufacturer, following an inspection of its oncology injectable formulation facility in Panelav, Gujarat, India. The inspection was conducted from October 4, 2022 to October 14, 2022. The company says it will address the observations within FDA’s stipulated time frame.
Source: Alembic Pharmaceuticals