In a shocking turn of events, Alkem Laboratories has uncovered that counterfeit drugs have been implicated in an ongoing investigation involving two of its popular products—Pan-D and Clavam 625. This discovery follows a report by the Central Drugs Standard Control Organization (CDSCO), which flagged certain batches of the drugs as substandard. However, Alkem Laboratories swiftly […]
Lupin, an Indian pharmaceutical company, has announced a strategic collaboration with Enzene Biosciences, a subsidiary of Alkem Laboratories, to introduce Cetuximab in India. Cetuximab is the first biosimilar developed for Eli Lilly and Company’s Cetuximab, a monoclonal antibody medication used in the treatment of various types of cancer, including head and neck cancer and metastatic […]
Alkem Laboratories said that it has been issued Form 483 with a couple of observations from the US Food and Drug Administration (FDA) pertaining to its manufacturing facility located in St. Louis in the US. The FDA carried out its inspection from 6 September to 14 September 2022, said the Indian pharma company. Alkem Laboratories […]
Alkem Laboratories Limited said that it has been issued Form 483 from the US Food and Drug Administration (FDA) following an inspection of its manufacturing facility in St. Louis, Missouri. The FDA has made three observations from its inspection that was held between 6 June 2022 and 17 June 2022, said the Indian pharma company. […]
Alkem Laboratories Limited (Alkem Labs) revealed that it has cleared an online inspection held by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of its bioequivalence center in Taloja, Maharashtra. According to the Indian pharma company, the inspection of the bioequivalence facility in Taloja was carried out from 31 January 2022 and 4 February […]
Alkem Laboratories Limited, an Indian pharma company, said that Instituto de Salud Pública de Chile (ISP Chile), the Chilean Public Health Institute, had carried out an inspection at its manufacturing facility in Daman, India from 28 March to 1 April 2022. Following the inspection, ISP Chile did not detect any observations critical to good manufacturing […]
Alkem Laboratories said that it has launched Ibuprofen and Famotidine Tablets (800 mg/26.6 mg) in the US having secured an approval from the US Food and Drug Administration (FDA). Ibuprofen and Famotidine Tablets is AB-rated generic therapeutic equivalent version of Horizon Medicines’ Duexis Tablets, 800 mg/26.6 mg. According to Alkem Laboratories, it is the first […]
Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company with two observations. Form 483 are given by the FDA when a company is found to have violated the Food Drug and Cosmetic (FD&C) Act and related acts. Alkem Laboratories said that the FDA had undertaken an […]
Alkem Laboratories and Tata Memorial Centre (TMC) have joined to set up an advanced radiotherapy facility in Muzaffarpur, Bihar as a part of the Homi Bhabha Cancer Hospital and Research Center (HBCHRC). As part of its CSR activity, Alkem Laboratories has approved the purchase of two advanced versions of the teletherapy and brachytherapy units for […]