A roundup of developments from Dominican Republic and Germany, (Fresenius Kabi), India (Aurobindo), and the US (FDA).

Dominican Republic

Fresenius Kabi Expands Apheresis Sets Production Site in Dominican Republic

Fresenius Kabi, a Bad Homburg, Germany-headquartered company providing medicines and technologies for infusion, transfusion and clinical nutrition, has inaugurated an expansion of the company’s production site in Haina, Dominican Republic, where the company manufactures apheresis sets. These products are used to collect blood components such as platelets or plasma.

Fresenius Kabi’s first plant building at the Haina site, which opened in 1987, covers around 18,000 square meters (195,000 square feet). The expansion, in which Fresenius Kabi is investing more than EUR 30 million ($33 million), doubles the size of the site’s newer, second plant building to around 15,000 square meters (160,000 square feet). The new space houses advanced production equipment, plasma-kit assembly lines and sterilization units that double the cleanroom and storage capacity. The site also includes a large warehouse.

Fresenius Kabi has almost 40,000 employees worldwide, including more than 3,500 in Haina. The disposables for transfusion medicine and cell technologies manufactured in Haina are exported to global markets.

Source: Fresenius Kabi

Germany

Fresenius Kabi Forms Joint Venture with Bio-Techne and Wilson Wolf

Fresenius Kabi, a Bad Homburg, Germany-headquartered company providing medicines and technologies for infusion, transfusion and clinical nutrition, has formed a joint venture with Bio-Techne, a provider of reagents and technologies for cell and gene therapy workflow, and Wilson Wolf, a provider of a scalable platform for the generation of personalized cell therapies, to support researchers and biopharmaceutical companies in the field of cell and gene therapy.

The joint venture is owned equally by the three partners and will focus on providing scalable manufacturing technologies and processes needed to develop and commercialize new cell and gene therapies. No financial terms were disclosed.

Source: Bio-Techne, Fresenius Kabi

India

Aurobindo Receives FDA Official Action Indicated Letter for Formulation Mfg Violations

The US Food and Drug Administration (FDA) has issued an official action indicated (OAI) letter to Aurobindo Pharma for its oral solids formulation manufacturing facility in Hyderabad, India. OAI means regulatory and/or administrative actions will be recommended. The agency conducted an inspection of the facility from October 7 to October 11, 2019.

Aurobindo says it believes that this OAI classification will not have any material impact on the existing revenues or the supplies to its US business. The company says it will work closely with the FDA to address the issues.

Source: Aurobindo Pharma

US

FDA Requests Withdrawal of Pneumonia Drug from the Market Due to Potential Risks

The US Food and Drug Administration (FDA) has requested that all current manufacturers of bacitracin for injection, an antibiotic for treating infants with pneumonia and empyema, voluntarily withdraw their products from the market. The FDA says it believes that the potential risks associated with bacitracin for injection are sufficiently serious to remove the drug from the market.

The FDA said that healthcare professionals no longer use bacitracin for injection to treat pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs) caused by Staphylococci, a type of bacteria, because other effective FDA-approved treatments are available that do not have the same serious risks, including nephrotoxicity (harm to the kidneys), anaphylactic reactions, and the need for repeated intramuscular injections.

In April 2019, the Antimicrobial Drugs Advisory Committee met and discussed the safety and effectiveness of bacitracin for injection. The advisory committee voted nearly unanimously, with one abstention, that the risks outweigh the benefits for the drug’s only approved indication. Based on the FDA’s review of currently available data, the FDA says it believes that the potential risks associated with bacitracin for injection are sufficiently serious to remove the drug from the market. This requested voluntary withdrawal does not impact approved topical or ophthalmic drugs that contain bacitracin.

Source: US Food and Drug Administration