The validations confirm the completion of the applications and commence the scientific review process
The WHO GMP approved vertically integrated ONCOLOGY unit of SAKAR has been selling products nationally since few quarters
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently
The product will be launched in March 2024
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
The said Unit complies with the prescribed Good Manufacturing practices as per relevant WHO technical Report Series
The observations do not pose any risk to site's compliance standards or its business continuity
Leishmaniasis is caused by protozoan parasites which are transmitted by the bite of infected female phlebotomine sandflies
Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA
VELSIPITY is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 years of age or older in the EU
Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy
Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease)
The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.
Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions
Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India
Exblifeb demonstrates remarkable efficacy in treating complicated Urinary Tract Infections (cUTI), pneumonia
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival
The company intends to respond to the two minor observations within the stipulated time
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