Indoco Remedies Parkinsons drug Rasagiline gets USFDA okay
New Delhi: Drugmaker, Indoco Remedies today received the US health regulator's final nod for Rasagiline 0.5 mg and 1 mg tablets for treating Parkinson's disease.
"Indoco Remedies Ltd. has received the final approval for its Abbreviated New Drug Application (ANDA) for Rasagiline 0.5 mg and 1 mg tablets from the United States Food & Drug Administration (USFDA)," Indoco said in a filing
Rasagiline is used for the treatment of Parkinson's disease. The market size of this product in the US as per IMS 2018 data is US$ 105 million.
Commenting on this encouraging development, Aditi Kare Panandikar, Managing Director, Indoco Remedies Ltd., said, "This is the first ANDA approval for Indoco after receipt of warning letter in March 2017 for Goa plant II and III. The Company has 32 ANDAs pending for approval for different dosage forms from this site."
Headquartered in Mumbai, Indoco Remedies has 9 manufacturing facilities, 6 of which are for FDFsand 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by USFDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc.
The company Indoco has 9 domestic marketing divisions with a strong brand portfolio in various therapeutic segments including Respiratory, Anti-Infective, Dental Care, Pain Management, Gastro-intestinal, Ophthalmic, Cardiovascular, Anti-Diabetics, Anti Obesity, etc.
Top Indoco brands include Cvdoparn, Febrex Plus, Sensodent-K, Oxipod, Cital, ATM, Cloben-G, Sensoform, Sensodent KF, Karvol Plus, Glychek, Kidodent, Carmicide, Bactogard, etc. On the international front, Indoco has tie-ups with large generic companies like Watson (Actavis)- USA and ASPEN-SouthAfrica.