Calcium Citrate

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 regulator, the Central Drugs Standard Control Organization (CDSCO), identified 185 drug samples as ‘ Not of Standard Quality ’ (NSQ) and flagged four others as ‘spurious’ during its monthly quality review for June. Of the total NSQ samples, 55 were flagged by Central Drugs Laboratories , while the remaining 130 were reported by State Drugs Testing Laboratories. In addition, the CDSCO drug alert identified four spurious drug samples, including a Cefixime Tablet from Bihar, an ointment of Heparin Sodium and Benzyl Nicotinate from Delhi, and two samples of Rosuvastatin and Fenofibrate Tablets — Rosuvas F 10 and Rosuvas F 20—collected from Telangana. A drug is deemed spurious if it qualifies certain conditions detailed under Section 17-B of the Drugs and Cosmetics Act, 1940. Of the 55 samples flagged as NSQ by central testing laboratories includes Dextrose Injection manufactured by Tam-Bran Pharmaceuticals; Azithromycin Tablet by Apple Formulations; Paracetamol Intravenous Infusion by D.J. Laboratories Telmisartan Tablets by Healers Lab and 51 other samples. The 130 samples flagged by state laboratories includes several common medicines and supplements such as Paracetamol, Pantoprazole, Calcium , Vitamin D3 tablets and several other common drugs. The identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters and the term NSQ has been defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. However, according to the Health Ministry, “identification of drug samples as 'NSQ' does not warrant any concerns on the other drug products available in the market. The CDSCO routinely notifies ‘'NSQ ' and spurious medicines based on a monthly review undertaken by the central and state drug regulatory bodies to ensure that these drugs are removed from the market and enforce quality norms. By Abhijeet Singh ,