Ditiazem Hydrochloride

Ahmedabad: Zydus Lifesciences announced that its Diltiazem Hydrochloride Tablets indicated for management of angina has received final approval from the US Food and Drug Administration ( US FDA ). Diltiazem is a calcium-channel blocker which works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle. The drug is indicated for the management of chronic stable angina and angina due to coronary artery spasm . According to IQVIA, as of June this year in the US the Diltiazem reported total sales of $13.9 million. As per the company release the drug will be produced at Zydus Baddi, Himachal Pradesh-based facility. With this approval, the Indian drugmaker now has 423 approvals and has filed 483 ANDAs since the commencement of the filing process in FY 2003-04. By Online Bureau ,

New Delhi: India’s drug price controller, NPPA has fixed the retail prices of 37 new drug including key type-2 diabetes formulations, antibiotics, cardiac therapies among several others. Issuing a gazette notification, the National Pharmaceutical Pricing Authority (NPPA) announced that the based on the decision of the 135th Authority meeting, the body has fixed retail prices of 37 formulations under Drugs (Prices Control) Order, 2013.” The notified list of 37 formulations includes key diabetes formulations of Empagliflozin, Sitagliptin, Meformin and Linagliptin. Additionally the list comprises formulation of Atorvastatin & Ezetimibe indicated for the treatment of high cholesterol and fats. The list further lunches other common anti-inflammatory formulations and drugs like Paracetamol, Diclofenac among several others. Under the Drugs Price Control Order any marketer, or manufacturers that intends to market a new drug in India is required to obtain a prior approval of the particular drug retail price from the NPPA and in case the fixed price is not complied, then the concerned manufacturer/marketing company is required to deposit the overcharged amount along with an interests per the relevant provision. However, the fixed retail prices are applicable only to the individual manufacturer / marketer who have applied for the same and are specified in the mentioned in the notified list. Meanwhile, in a separate gazette notification the national drug price controller has fixed the ceiling price of four scheduled formulations. The latest notified list includes Ipratropium, Sodium nitroprusside, Povidone iodine, and Diltiazem. Ipratropium is a ‘respirator solution’ indicated for the treatment of condictions like COPD and the drug ceiling price is capped at ₹2.96 per unit. Sodium nitroprusside is an injectable used to control high blood pressure and ceiling price of the formulation is fixed at ₹28.99. The other two scheduled formulations Povidone iodine and Diltiazem are used to treat skin infections and angina (severe chest pain), and the their ceiling price is fixed at ₹6.26 per ml and ₹26.72 per capsule respectively. According to the Ministry of Health and Family Welfare , the National list of Essential Medicines includes those formulations which are indicated for the treatment of diseases which is a public health problem in India, recommended under National Health Programs of India and several other factors. The prices of drugs categorised in the list are fixed and maintained by the NPPA to ensure the affordability of essential drugs for consumers and currently the list includes over 900 formulations. By Online Bureau ,