Glenmark gets USFDA nod for generic medication

The company has received final approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of Horizon Therapeutics’ Buphenyl, the Mumbai-based drug maker said in a statement.

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lastRsrs[e]= stkId; if(lastRsrs.length > 0) { var resStr=”; var url = ‘//www.moneycontrol.com/mccode/common/saveWatchlist.php’; $ .get( “//www.moneycontrol.com/mccode/common/rhsdata.html”, function( data ) { $ (‘#backInner1_rhsPop’).html(data); $ .ajax({url:url, type:”POST”, dataType:”json”, data:{q_f:typparam1,wSec:secglbVar,wArray:lastRsrs}, success:function(d) { if(typparam1==’1′) // rhs { var appndStr=”; var newappndStr = makeMiddleRDivNew(d); appndStr = newappndStr[0]; var titStr=”;var editw=”; var typevar=”; var pparr= new Array(‘Monitoring your investments regularly is important.’,’Add your transaction details to monitor your stock`s performance.’,’You can also track your Transaction History and Capital Gains.’); var phead =’Why add to Portfolio?’; if(secglbVar ==1) { var stkdtxt=’this stock’; var fltxt=’ it ‘; typevar =’Stock ‘; if(lastRsrs.length>1){ stkdtxt=’these stocks’; typevar =’Stocks ‘;fltxt=’ them ‘; } } //var popretStr =lvPOPRHS(phead,pparr); //$ (‘#poprhsAdd’).html(popretStr); 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alert(‘Please select at least one ‘+disNam); } } else { AFTERLOGINCALLBACK = ‘overlayPopup(‘+e+’, ‘+t+’, ‘+n+’)’; commonPopRHS(); /*work_div = 1; typparam = t; typparam1 = n; check_login_pop(1)*/ } } function pcSavePort(param,call_pg,dispId) { var adtxt=”; if(readCookie(‘nnmc’)){ if(call_pg == “2”) { pass_sec = 2; } else { pass_sec = 1; } var url = ‘//www.moneycontrol.com/mccode/common/saveWatchlist.php’; $ .ajax({url:url, type:”POST”, //data:{q_f:3,wSec:1,dispid:$ (‘input[name=sc_dispid_port]’).val()}, data:{q_f:3,wSec:pass_sec,dispid:dispId}, dataType:”json”, success:function(d) { //var accStr= ”; //$ .each(d.ac,function(i,v) //{ // accStr+=”+v.nm+”; //}); $ .each(d.data,function(i,v) { if(v.flg == ‘0’) { var modalContent = ‘Scheme added to your portfolio.’; var modalStatus = ‘success’; //if error, use ‘error’ $ (‘.mc-modal-content’).text(modalContent); $ (‘.mc-modal-wrap’).css(‘display’,’flex’); $ (‘.mc-modal’).addClass(modalStatus); //$ (‘#acc_sel_port’).html(accStr); //$ (‘#mcpcp_addportfolio .form_field, .form_btn’).removeClass(‘disabled’); 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Glenmark Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market Sodium Phenylbutyrate tablets, used in treating urea cycle disorders, in America.

The company has received final approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of Horizon Therapeutics’ Buphenyl, the Mumbai-based drug maker said in a statement.

According to IQVIA sales data for 12-month period ended September 2022, Buphenyl had annual sales of around USD 8.7 million.

Glenmark’s current portfolio consists of 177 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA.