Dr Reddy’s and Zydus Lifesciences are recalling certain medications in the US due to concerns over their quality.
Dr. Reddy’s and Zydus Lifesciences, two major Indian pharmaceutical companies, have initiated recalls of certain medicines in the US due to quality issues. The recalls were voluntarily undertaken by the companies by the US Food and Drug Administration (US FDA).
Dr. Reddy’s is recalling several lots of its Metformin Hydrochloride Extended-Release Tablets, which are used to treat type 2 diabetes, due to the detection of N-Nitrosodimethylamine (NDMA) impurities above the acceptable daily intake limit. NDMA is a known carcinogen and its presence in medications has been a major concern in recent years.
Zydus Lifesciences, on the other hand, is recalling certain lots of its Lisinopril Tablets, which are used to treat high blood pressure and heart failure. The recall was initiated due to the presence of an impurity called N-Methylnivaldipine, which is a known byproduct of the manufacturing process.
Both recalls are classified as Class II recalls, which means that the use of the affected products may cause temporary or medically reversible adverse health consequences. However, the FDA has stated that there is no immediate risk to patients who have taken the affected medications, and patients are advised to continue taking their medications as directed until they can obtain a replacement or alternative treatment.
The recalls are a result of the US FDA’s ongoing efforts to ensure the quality and safety of medications marketed in the US. The agency has been working closely with pharmaceutical companies to identify and address quality issues, including the presence of impurities in medications.
Dr. Reddy’s and Zydus Lifesciences have stated that they are committed to ensuring the quality and safety of their products and are cooperating fully with the US FDA to resolve the issues. The companies have also notified their distributors and retailers to stop further distribution of the affected products and to return any unused products to the company.
The recalls highlight the importance of quality control and monitoring in the pharmaceutical industry. Patients who have been taking the affected medications are advised to contact their healthcare provider or pharmacist for guidance on what to do next. The US FDA will continue to monitor the situation and take any necessary actions to ensure the safety and quality of medications marketed in the US.
Biocon’s recently established US facility has successfully overcome a crucial regulatory obstacle imposed by the FDA.
Biocon Ltd. has successfully completed a critical Good Manufacturing Practices (GMP) inspection by the US Food and Drug Administration (FDA) at its first manufacturing facility in the US, located in Cranbury, New Jersey. The inspection, which is mandatory for supplying the regulated US market, resulted in a single minor observation that will be addressed within the stipulated time frame. The company has assured stakeholders that this outcome will not impact current or planned business operations from the site.
The Cranbury facility, which was inaugurated in September, is a state-of-the-art plant that represents a strategic investment to strengthen Biocon’s footprint in the US market. The site is designed to enhance supply chain resilience and enable faster access to the company’s portfolio of products for patients across the region. The facility is already operational, with some products having been commissioned from the site, and is expected to play a pivotal role in Biocon’s mission to expand global access to essential medicines.
The Cranbury facility has an annual production capacity of 2 billion tablets and has already commercialized a few products, with several more in the pipeline. Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc. in 2023 and has since invested over $30 million to establish a state-of-the-art plant. This investment helps Biocon diversify its manufacturing base, strengthen its supply chain, and accelerate the expansion of its global footprint.
The successful GMP inspection and the operationalization of the Cranbury facility mark a significant milestone for Biocon’s US operations. The company is now well-positioned to bring its high-quality, affordable therapies to patients in the US more efficiently and reliably. The facility will enable faster access to essential therapies, enhance supply reliability, and strengthen connections with partners and healthcare providers, ultimately benefiting patients across the United States. With its strategic location and state-of-the-art infrastructure, the Cranbury facility is poised to play a critical role in Biocon’s global expansion plans.
Lupin receives one observation from the USFDA for its Somerset facility
Lupin, a pharmaceutical company, has received one observation from the US Food and Drug Administration (USFDA) for its facility located in Somerset, New Jersey. The USFDA observation is a result of an inspection conducted by the regulatory agency, which identified a single issue that needs to be addressed by the company.
Although the specific details of the observation have not been disclosed, it is likely that the issue is related to the company’s manufacturing processes, quality control systems, or other aspects of its operations. The USFDA observation is not a formal warning, but rather a notification that the company needs to take corrective action to ensure compliance with regulatory requirements.
The receipt of a USFDA observation can have significant implications for a pharmaceutical company, as it can impact the company’s ability to manufacture and distribute its products in the US market. However, it is worth noting that a single observation is generally considered to be a relatively minor issue, and it is not uncommon for companies to receive observations during USFDA inspections.
Lupin has not commented on the specific details of the observation, but the company has stated that it is committed to addressing the issue and ensuring that its facility is in compliance with all regulatory requirements. The company will likely need to submit a corrective action plan to the USFDA, which will outline the steps it will take to address the observation and prevent similar issues from arising in the future.
The USFDA inspection and observation process is an important aspect of ensuring the quality and safety of pharmaceutical products in the US market. The agency conducts regular inspections of pharmaceutical manufacturing facilities to ensure that they are in compliance with regulatory requirements, such as good manufacturing practices (GMPs) and quality control systems.
In general, the USFDA inspection process involves a thorough review of a company’s manufacturing processes, quality control systems, and other aspects of its operations. The agency will typically conduct an on-site inspection of the facility, during which inspectors will review documents, observe manufacturing processes, and conduct interviews with company personnel. If any issues are identified during the inspection, the USFDA will issue an observation, which the company must address through a corrective action plan.
Dr Reddy’s and Zydus have initiated recalls of certain products in the US market due to concerns regarding their quality.
Dr. Reddy’s Laboratories and Zydus Lifesciences, two major pharmaceutical companies, are recalling certain products in the US due to manufacturing issues. According to the US Food and Drug Administration (USFDA), Dr. Reddy’s Laboratories is recalling 571 vials of Succinylcholine Chloride Injection, which is used to relax muscles. The recall was initiated due to an “Out-of-Specification result during the six-month stability testing” of the product.
The recall, which was initiated on September 26, is classified as a Class II recall, meaning that the use of the product may lead to temporary or medically reversible health consequences. Dr. Reddy’s Laboratories has a subsidiary in Princeton, New Jersey, which is handling the recall.
Zydus Lifesciences is also recalling over 1,500 boxes of Entecavir tablets, an antiviral medication used to treat chronic hepatitis B virus. The recall was initiated due to “failed impurity/degradation specifications” and affects 912 and 600 bottles of the tablets in strengths of 0.5 mg and 1 mg, respectively. The recall, which was initiated on September 24, is also classified as a Class II recall.
The USFDA’s Enforcement Report stated that both recalls are nationwide and were initiated by the companies’ US-based arms. The recalls highlight the importance of maintaining high standards of quality and manufacturing in the pharmaceutical industry. India has the highest number of USFDA-compliant pharmaceutical plants outside of the US, and companies like Dr. Reddy’s Laboratories and Zydus Lifesciences must adhere to strict guidelines to ensure the safety and efficacy of their products.
The recalls are a precautionary measure to prevent any potential harm to patients, and the companies are taking steps to rectify the issues and prevent similar problems in the future. The USFDA’s classification of the recalls as Class II indicates that the risks associated with the products are minimal, but the companies are still taking proactive steps to address the issues and maintain patient safety.
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