Category: Supply Chain

Supply Chain

FDA Eases Shortage Crisis by Importing Additional Cancer Drugs from China

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  • July 12, 2023
  • 3 min read
Adderall supply shortage
Supply Chain

Adderall supply shortage spreads to Takeda’s ADHD medication

Editorial Team
  • June 26, 2023
  • 3 min read
Chemotherapy Drug Shortages
Supply Chain

Survey Reveals Ongoing Chemotherapy Drug Shortages

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  • June 14, 2023
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Global Health Pharma
Supply Chain

Global Health Pharma’s Indian Facility Flagged Down by the FDA for Deficient Manufacturing Process

Editorial Team
  • April 8, 2023
  • 3 min read
Apotex to recall glaucoma drug after sterility concerns  Apotex, Canada's largest generic drug maker, has announced a recall of six lots of brimonidine tartrate ophthalmic solution, which is used to treat glaucoma and ocular hypertension.  The recall comes after Apotex discovered cracks on the caps of certain brimonidine tartrate bottles, which could compromise the sterility of the drug and potentially cause unwanted side effects. Apotex reported no patient complaints or safety signals tied to the recall. The affected bottles were shipped across the United States between April 2022 and February 2023. Apotex is reaching out to wholesalers, distributors, warehouses, and pharmacies to track down the affected batches. The recall only pertains to brimonidine tartrate in the 0.15% presentation from Apotex. This is not the first time Apotex has faced regulatory scrutiny in the United States. In 2019, the company withdrew 31 of its generic drug approvals from the FDA after the regulator identified manufacturing issues at two plants in India. In 2021, Apotex initiated two recalls: one for the anticoagulant enoxaparin and another for three lots of 2-mg guanfacine extended-release tablets, used to treat attention deficit/hyperactivity disorder. Despite these regulatory setbacks, Apotex has enjoyed a relatively good run. Apotex has undergone a CEO switch and a price-fixing settlement, and the company sold itself to private investment firm SK Capital in September 2022. The terms of the sale remain undisclosed. At the time of the sale, Apotex employed approximately 8,000 people across more than 100 countries. The company has a significant footprint in India and Mexico, in addition to Canada and the United States. In 2019, Apotex was valued at around $3 billion. The pharmaceutical industry is no stranger to recalls. In recent years, several high-profile recalls have made headlines. In 2019, for example, Sandoz issued a recall of its prescription heartburn medication ranitidine after discovering that the drug contained a probable human carcinogen. In 2020, Mylan recalled several batches of its epinephrine auto-injectors, used to treat severe allergic reactions, due to a potential failure to activate. Recalls can have significant financial and reputational consequences for pharmaceutical companies. In addition to the cost of the recall itself, companies may face legal liabilities, lost revenue, and damage to their brand reputation. As such, many companies are taking steps to prevent recalls from occurring in the first place, including investing in quality control measures and improving their supply chain management. Brimonidine Tartrate Ophthalmic Solution is a medication that stimulates alpha-adrenergic receptors and is prescribed to reduce elevated intraocular pressure or IOP in individuals suffering from open-angle glaucoma or ocular hypertension. The drug has been found to be associated with a safety concern, which has prompted Apotex to recall six lots of the drug. The company has taken the step as a precautionary measure after it discovered cracks on the caps of certain bottles containing brimonidine tartrate.  The company is reaching out to wholesalers, distributors, warehousing chains, mail-order pharmacies, and long-term care pharmacies to identify the affected bottles, which were shipped between April 2022 and February 2023 across the United States. Also read, Amidst bacterial outbreak, FDA issues second warning to Delsam Pharma’s Artificial Eye Ointment
Supply Chain

Apotex to recall glaucoma drug after sterility concerns

Editorial Team
  • March 6, 2023
  • 3 min read
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