Novugen Pharma Malaysia Achieves Zero Form 483 Citations in Recent USFDA Audit
Novugen Pharma Sdn. Bhd. proudly announces the successful completion of recent USFDA audit, achieving zero Form 483 citations and No Action Indicated (NAI) status—the highest level of compliance for USFDA-registered manufacturing facilities. This milestone positions Novugen among a select few global companies meeting these standards and reflects the dedication of its team. - October 29, 2024
Novugen Launches Pazopanib Tablets, 200mg, in the U.S. Following ANDA Approval by USFDA
Novugen has launched Pazopanib tablets, 200mg, in the U.S. after receiving ANDA approval from USFDA on April 23, 2024. This significant milestone demonstrates Novugen's continued growth in the U.S. pharmaceutical market with a complex anticancer drug, the generic equivalent of Votrient, used to treat advanced renal cell carcinoma (RCC) and advanced soft tissue sarcoma (STS). - May 07, 2024
Novugen Pharma (USA) LLC Launches ANDA Approved Midodrine 2.5mg, 5mg & 10mg
Novugen Pharma (USA) LLC has launched Midodrine 2.5mg, 5mg and 10mg in the U.S. upon the approval from ANDA by FDA. Novugen’s Midodrine will be manufactured in Malaysia by Novugen Pharma Sdn. Bhd. Midodrine is indicated for the treatment of symptomatic orthostatic hypotension, a condition defined as a sudden drop in blood pressure upon standing from a sitting or supine position. - November 07, 2023
Novugen Pharma Became the First Pharmaceutical Company in Malaysia to Receive USFDA Approval for Its Manufacturing Facility
The Company was audited in September 2022 and USFDA issued an Establishment Inspection Report (EIR) in November 2022. Novugen Pharma is the first USFDA approved pharmaceutical manufacturing in Malaysia and the only in Southeast Asia. - November 22, 2022