Dr. Reddy’s Laboratories has launched Sapropterin Dihydrochloride Powder for Oral Solution, 100mg, a generic of BioMarin’s Kuvan (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, approved by the US Food and Drug Administration (USFDA) for the treatment of phenylketonuria. Sapropterin dihydrochloride is indicated for the treatment of variant types of phenylketonuria (hyperphenylalaninaemia) associated with deficiency […]
Dr. Reddy’s Laboratories said that it has started the process to seek the emergency use authorization (EUA) for the Russian Covid-19 vaccine Sputnik V from the Drugs Controller General of India (DCGI). The Indian pharma company, as part of the review process, will provide the safety profile of the phase 2 trial and interim data […]
Dr. Reddy’s Laboratories, an Indian pharma company, has launched Fluphenazine Hydrochloride Tablets, USP, in the US market. Fluphenazine Hydrochloride Tablets, USP is a therapeutic equivalent generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, which has approval from the US Food and Drug Administration (FDA) for the management of manifestations […]
Dr. Reddy’s Laboratories has secured the go-ahead from the Drugs Control General of India (DCGI) to begin phase 3 clinical trial for the Russian Covid-19 vaccine Sputnik V in India. The Indian pharma company plans to hold the phase 3 study on 1500 volunteers as part of the randomized, double-blind, parallel-group, placebo-controlled study. G V […]
Indian pharma company Dr. Reddy’s Laboratories announced that Sputnik V, a registered Covid-19 vaccine in Russia, has succeeded in a phase 2 trial in India by meeting the primary endpoint of safety. An independent data and safety monitoring board (DSMB) has recommended the Sputnik V Covid-19 vaccine to be advanced to a phase 3 trial […]
Indian pharma company Dr. Reddy’s Laboratories has launched a generic version of phenylalanine hydroxylase activator Sapropterin Dihydrochloride Tablets, for oral use, in the US market. Sapropterin Dihydrochloride Tablets are indicated in the US for reducing blood phenylalanine (Phe) levels in adult and pediatric patients, aged one month and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- […]
Russian Direct Investment Fund (RDIF) and Dr. Reddy’s Laboratories have agreed to cooperate on clinical trials and distribution of the Sputnik V coronavirus vaccine in India. After receiving regulatory approval in India, the Russian sovereign wealth fund will supply 100 million doses of the vaccine to Dr. Reddy’s. The Sputnik V coronavirus vaccine, which is […]
Dr Reddy’s Laboratories has agreed to acquire a portfolio of 42 approved, non-marketed abbreviated new drug applications (ANDAs) in the US, which includes more than 30 generic injectable products, from an undisclosed seller. The generic injectable products would need technology transferred and may be launched within 1-2 years. According to IQVIA, the value of the […]
Dr. Reddy’s Laboratories has announced the appointment of Marc Kikuchi as the CEO of its North America Generics unit. Kikuchi, who brings over 20 years of industry experience, will assume his new role at the company’s Princeton office in the United States. His leadership will oversee Dr. Reddy’s North American Generics business as the company […]
