Global Pharma Briefs: News from Europe, Asia and the Middle EastBy
A roundup of developments and latest news from Canada (Health Canada), Germany (Merz and Oncotec), India (Lupin) and the US (Darmerica).
Health Canada Requests Companies Stop Ranitidine Distribution for NDMA Assessment
Health Canada, the regulatory agency in Canada, has requested that companies marketing ranitidine products in Canada to stop any further distribution until evidence is provided to demonstrate that they do not contain an impurity called N-nitrosodimethylamine (NDMA) above acceptable levels.
One company, Sandoz Canada, is recalling its oral prescription products in Canada and other countries after testing identified levels of NDMA above what is considered acceptable if the drug were to be taken over a lifetime.
The request to stop distribution means the existing stock of ranitidine products currently available in pharmacies or at retail stores may continue to be sold. Ranitidine is available in Canada over-the-counter (OTC) and by prescription. OTC ranitidine is approved to prevent and relieve heartburn associated with acid indigestion and sour stomach. Prescription ranitidine is used to reduce stomach acid for the treatment and prevention of various conditions, such as heartburn, ulcers of the stomach and intestines, and gastroesophageal reflux disease.
Health Canada continues to gather and share information with other regulators, including the US Food and Drug Administration and the European Medicines Agency, and with Canadian companies. Health Canada has been working to address the issue of NDMA and similar impurities, known as nitrosamines, found in certain “sartan”” angiotensin receptor blocker blood pressure medications since 2018.
Source: Health Canada
Merz and Oncotec Invest About $55 Million in Dessau Facilities
Merz, an aesthetics and neurotoxins company, has opened a new filler plant in BioPharmaPark, Dessau-Rosslau, Germany. In addition, Oncotec Pharma, a contract manufacturer of cytostatics and immunosuppressants, has invested EUR 35 million ($38 million) at its site in BioPharmaPark in Dessau-Rosslau.
Merz constructed its new plant for its Belotero, hyaluronic acid dermal fillers, expanding the range of products manufactured at its Dessau site. The new building represents a EUR 15 million ($16 million) investment and spans over 1,200 square meters on three floors. About 150 Merz employees are currently working at the Dessau site. Production takes place under cleanroom conditions. In 2002, Merz established its initial production footprint in the BioPharmaPark in Dessau to manufacture the active pharmaceutical ingredient, botulinum neurotoxin.
Oncotec, which manufactures medicines in cancer and autoimmune diseases, specializes in the production and development as well as the freeze-drying of liquid cytostatics. Oncotec has launched a robot-controlled filling line and installation for the fully automatic visual inspection of syringes.
FDA Issues Warning Letter for Lupin’s Finished Dose Mandideep Facility
The US Food and Drug Administration (FDA) has issued a Warning Letter to Lupin Limited for its Mandideep (Unit 1), India facility. This letter follows an earlier intimation issued by the FDA in March 2019, wherein the agency had classified its inspection conducted at the Mandideep facility in December 2018 as Official Action Indicated. Official Action Indicated is a classification made by the FDA following an inspection to indicate that regulatory and/or administrative actions will be recommended.
There are no new drug master files and abbreviated new drug applications pending review or approval from the Mandideep (Unit 1) facility, according to Lupin. Lupin says it does not believe that the Warning Letter will have an impact or cause a disruption of supplies or impact existing revenues from operations of this facility.
Lupin says it will work with the FDA to resolve these issues.
BiomX Completes Construction of Clinical Phage Mfg Facility in Israel
BiomX, a microbiome developer of natural and engineered phage therapies, has completed construction of a new clinical manufacturing facility in Ness Ziona, Israel for the company’s candidate phage products. The company says the facility could be expanded to support commercial manufacturing needs in the future.
Phage are viruses that specifically infect bacteria. BiomX develops a specific composition of phage as product candidates targeting each of its bacterial targets. Phage manufacturing requires first the manufacturing of a specific bacterial strain, that in a second stage, is used to host the growth of the phage.
The new facility has been designed to support the necessary manufacturing requirements for BiomX’s future clinical development, including the manufacturing of BX002, a drug candidate phage composition designed to target bacterial strains that potentially have a role in the onset and aggravation of inflammatory bowel disease (IBD). BiomX says clinical trials are expected to start in 2020. In its current configuration, the site can support clinical manufacturing for BiomX’s future Phase I and Phase II trials in both IBD and primary sclerosing cholangitis, a chronic liver disease, and can be expanded for Phase III and commercial stages.
Darmerica Announces Voluntary Recall of API Quinacrine Dihydrochloride
Darmerica, a US-based prescription drug repackager, is voluntarily recalling two lots of quinacrine dihydrochloride, a bulk active pharmaceutical ingredient, due to a label mix-up.
The product intended for further compounding use by pharmacies labeled as quinacrine API was tested and identified as artemisinin API. Artemisinin and its semisynthetic derivatives are a group of drugs used against malaria.
The product is used as an antiprotozoal, antirheumatic, intrapleural sclerosing agent and was packaged in amber high-density polyethylene (HDPE) bottles. Quinacrine dihydrochloride was distributed nationwide to 14 compounding pharmacies.