A roundup of manufacturing news from Pfizer, Sandoz, Takeda, and Jazz Pharmaceuticals.

Pfizer Recalls Anti-Hypertensive Drug Due to Nitrosamine Impurity
Pfizer is voluntarily recalling an anti-hypertensive drug, Accuretic (quinapril HCl/hydrochlorothiazide) tablets, distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-nitroso-quinapril, above the acceptable daily intake level. Pfizer is recalling six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets. Nitrosamines are a potential carcinogenic.

Source: Pfizer

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Sandoz Recalls 13 Lots of Pain Drug for Nitrosamine Impurity
Sandoz, the generics and biosimilars business of Novartis, s initiating a voluntary recall of 13 lots of oral orphenadrine citrate 100-mg extended-release (ER) tablets to the consumer level due to the presence of a nitrosamine impurity, N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA or nitroso-ophenadrine), which has the potential to be above the U.S. Food and Drug Administration (FDA)’s acceptable daily Intake (ADI) limit of 26.5 ng/day. Nitrosamines are substances with carcinogenic potency when present above the allowable exposure limits

The impurity was detected in the lots during recent testing. These 13 lots were shipped to customers from August 2019 to April 2021. Sandoz says it has not received (as of March 21, 2022) any reports of adverse events related to the presence of a nitrosamine impurity in the lot.

Orphenadrine citrate ER tablets are used as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The product is packaged in 100-count and 1,000-count bottles and was distributed nationwide in the US to wholesalers and distributors.

Source: US Food and Drug Administration

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Takeda Receives FDA Completer Response Letter for Mfg Issue
Takeda has received a Complete Response Letter from the US Food and Drug Administration (FDA) for Natpara (parathyroid hormone) in response to a prior approval supplement (PAS) submitted in August 2021 to address the potential for rubber particulate formation that led to the US recall of the product in September2019.

The CRL indicates that the FDA has completed its review of the Natpara PAS and determined that it cannot be approved in its present form. Takeda says it is evaluating the details of the CRL to determine next steps; the commercial return of the drug n the US is for now indefinitely delayed. Natpara is used with calcium and vitamin D to control low blood calcium (hypocalcemia) in people with low parathyroid hormone blood levels(hypoparathyroidism).

Source: Takeda

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Jazz Pharma Investing $100 M for Cannabis-Based Mfg Facility
Jazz Pharmaceuticals, a Dublin, Ireland-based biopharmaceutical company, and its subsidiary, GW Pharmaceuticals, a biopharmaceutical company developing cannabis-based medicines, have initiated construction of new, $100-million manufacturing facility at Kent Science Park (KSP) in Sittingbourne, UK

The new facility will be approximately 60,000 square feet, with an investment of over $100 million. Due to open in 2024, the facility is designed to support the company’s two regulatory-approved cannabis-based medicines and support future capacity for new medicines under development. Jazz currently manufactures the extract, active pharmaceutical ingredients, and the formulated drug products at KSP, occupying 12 buildings with more than 400 employees.

Source: Jazz Pharmaceuticals