Swedish contract development and manufacturing organization (CDMO) Recipharm has commissioned a new manufacturing facility in Bengaluru, India, dedicated to the production of nonbacterial beta-lactam tablets.
The company said the site was developed in response to evolving regulatory requirements and has been designed to comply with standards set by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Details of the facility were disclosed in a company press release issued on Jan. 26.
Recipharm stated that development work on the Bengaluru plant was initiated following the release of the FDA’s final draft guidance on nonbacterial beta-lactam drugs in June 2022. The guidance outlines a range of manufacturing measures aimed at ensuring that nonbacterial beta-lactam compounds are produced in a manner that fully eliminates the risk of cross-contamination with other medicinal products.
According to the guidance, safety considerations underpin these requirements, as even trace exposure to beta-lactam compounds may result in allergic reactions in certain patient populations.
The company said the commissioning of the new facility has enabled it to establish what it described as a major partnership with an unnamed, leading innovative biopharmaceutical company. Under the terms of this partnership, Recipharm will manufacture the partner’s nonbacterial beta-lactam tablets at the Bengaluru site. The company did not disclose the identity of the partner or provide additional information regarding the scope of the collaboration beyond its focus on nonbacterial beta-lactam tablet production.
As part of the agreement, Recipharm has committed to installing new specialized manufacturing capabilities at the Bengaluru facility. The company said these additional capabilities are intended to support the requirements of the current partnership. Recipharm also noted that the expanded infrastructure could be used to support future collaborations involving beta-lactam manufacturing. The company did not provide specific details regarding the facility’s manufacturing capacity or the level of capital investment associated with the project.
Issues related to beta-lactam cross-contamination were highlighted publicly in September 2023, when antifungal drug developer Scynexis disclosed manufacturing concerns related to its drug Brexafemme. Scynexis said that a review of its manufacturing process conducted by GSK, which had entered into a licensing deal for the drug, led to a recall of Brexafemme and a pause of all clinical trials involving the medicine.
According to a Scynexis securities filing, the concerns arose because Brexafemme was manufactured on equipment that was also used to produce non-antibacterial beta-lactam drug substance, which can cause hypersensitivity or allergic reactions in some individuals. The FDA later lifted a clinical hold on Brexafemme that had been in place for 19 months and was tied to the beta-lactam manufacturing concerns.
Commenting on regulatory developments, Recipharm Chief Executive Officer Greg Behar said, “Regulatory change should not become a barrier to innovation or patient access.” He added that Recipharm’s role as a CDMO involves adapting to customer needs and changes in how markets are regulated, while evolving manufacturing capabilities to support partners’ research and development activities.
Recipharm operates a total of 17 facilities across nine countries. The company states that its global sites are equipped to support manufacturing and development of drug substances and drug products, as well as projects involving advanced therapies. According to information published by the company, the Bengaluru site comprises four large standalone facilities designed to support the production of solid, semisolid, and oral liquid dosage forms.
Recipharm Expands Manufacturing in India
Recipharm has commissioned a new pharmaceutical manufacturing facility in Bengaluru, India, focused on nonbacterial beta-lactam tablet production. The site strengthens Recipharm’s global solid-dose manufacturing network.
Advanced Tablet Production Capabilities
The Bengaluru facility is equipped with modern technology and operates under strict international quality and regulatory standards. Through this expansion, Recipharm aims to meet growing global demand for safe and reliable nonbacterial beta-lactam formulations.
Strategic Growth for Recipharm
By investing in India, Recipharm reinforces its long-term growth strategy, improves supply chain efficiency, and enhances support for pharmaceutical partners worldwide.
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