The US Food and Drug Administration (USFDA) inspected AnaCipher from September 12-16, 2022, Indoco Remedies said in a regulatory filing.
PTI
September 19, 2022 / 01:13 PM IST
‘); $ (‘#lastUpdated_’+articleId).text(resData[stkKey][‘lastupdate’]); //if(resData[stkKey][‘percentchange’] > 0){ // $ (‘#greentxt_’+articleId).removeClass(“redtxt”).addClass(“greentxt”); // $ (‘.arw_red’).removeClass(“arw_red”).addClass(“arw_green”); //}else if(resData[stkKey][‘percentchange’] < 0){ // $ (‘#greentxt_’+articleId).removeClass(“greentxt”).addClass(“redtxt”); // $ (‘.arw_green’).removeClass(“arw_green”).addClass(“arw_red”); //} if(resData[stkKey][‘percentchange’] >= 0){ $ (‘#greentxt_’+articleId).removeClass(“redtxt”).addClass(“greentxt”); //$ (‘.arw_red’).removeClass(“arw_red”).addClass(“arw_green”); $ (‘#gainlosstxt_’+articleId).find(“.arw_red”).removeClass(“arw_red”).addClass(“arw_green”); }else if(resData[stkKey][‘percentchange’] < 0){ $ (‘#greentxt_’+articleId).removeClass(“greentxt”).addClass(“redtxt”); //$ (‘.arw_green’).removeClass(“arw_green”).addClass(“arw_red”); $ (‘#gainlosstxt_’+articleId).find(‘.arw_green’).removeClass(“arw_green”).addClass(“arw_red”); } $ (‘#volumetxt_’+articleId).show(); $ (‘#vlmtxt_’+articleId).show(); $ (‘#stkvol_’+articleId).text(resData[stkKey][‘volume’]); $ (‘#td-low_’+articleId).text(resData[stkKey][‘daylow’]); $ (‘#td-high_’+articleId).text(resData[stkKey][‘dayhigh’]); $ (‘#rightcol_’+articleId).show(); }else{ $ (‘#volumetxt_’+articleId).hide(); $ (‘#vlmtxt_’+articleId).hide(); $ (‘#stkvol_’+articleId).text(”); $ (‘#td-low_’+articleId).text(”); $ (‘#td-high_’+articleId).text(”); $ (‘#rightcol_’+articleId).hide(); } $ (‘#stk-graph_’+articleId).attr(‘src’,’//appfeeds.moneycontrol.com/jsonapi/stocks/graph&format=json&watch_app=true&range=1d&type=area&ex=’+stockType+’&sc_id=’+stockId+’&width=157&height=100&source=web’); } } } }); } $ (‘.bseliveselectbox’).click(function(){ $ (‘.bselivelist’).show(); }); function bindClicksForDropdown(articleId){ $ (‘ul#stockwidgettabs_’+articleId+’ li’).click(function(){ stkId = jQuery.trim($ (this).find(‘a’).attr(‘stkid’)); $ (‘ul#stockwidgettabs_’+articleId+’ li’).find(‘a’).removeClass(‘active’); $ (this).find(‘a’).addClass(‘active’); stockWidget(‘N’,stkId,articleId); }); $ (‘#stk-b-‘+articleId).click(function(){ stkId = jQuery.trim($ (this).attr(‘stkId’)); stockWidget(‘B’,stkId,articleId); $ (‘.bselivelist’).hide(); }); $ (‘#stk-n-‘+articleId).click(function(){ stkId = jQuery.trim($ (this).attr(‘stkId’)); stockWidget(‘N’,stkId,articleId); $ (‘.bselivelist’).hide(); }); } $ (“.bselivelist”).focusout(function(){ $ (“.bselivelist”).hide(); //hide the results }); function bindMenuClicks(articleId){ $ (‘#watchlist-‘+articleId).click(function(){ var stkId = $ (this).attr(‘stkId’); overlayPopupWatchlist(0,2,1,stkId); }); $ (‘#portfolio-‘+articleId).click(function(){ var dispId = $ (this).attr(‘dispId’); pcSavePort(0,1,dispId); }); } $ (‘.mc-modal-close’).on(‘click’,function(){ $ (‘.mc-modal-wrap’).css(‘display’,’none’); $ (‘.mc-modal’).removeClass(‘success’); $ (‘.mc-modal’).removeClass(‘error’); }); function overlayPopupWatchlist(e, t, n,stkId) { $ (‘.srch_bx’).css(‘z-index’,’999′); typparam1 = n; if(readCookie(‘nnmc’)) { var lastRsrs =new Array(); 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); //$ (‘.btmbgnwr’).show(); var tickTxt =’‘; if(typparam1==1) { var modalContent = ‘Watchlist has been updated successfully.’; var modalStatus = ‘success’; //if error, use ‘error’ $ (‘.mc-modal-content’).text(modalContent); $ (‘.mc-modal-wrap’).css(‘display’,’flex’); $ (‘.mc-modal’).addClass(modalStatus); //var existsFlag=$ .inArray(‘added’,newappndStr[1]); //$ (‘#toptitleTXT’).html(tickTxt+typevar+’ to your watchlist’); //if(existsFlag == -1) //{ // if(lastRsrs.length > 1) // $ (‘#toptitleTXT’).html(tickTxt+typevar+’already exist in your watchlist’); // else // $ (‘#toptitleTXT’).html(tickTxt+typevar+’already exists in your watchlist’); // //} } //$ (‘.accdiv’).html(”); //$ (‘.accdiv’).html(appndStr); } }, //complete:function(d){ // if(typparam1==1) // { // watchlist_popup(‘open’); // } //} }); }); } else { var disNam =’stock’; if($ (‘#impact_option’).html()==’STOCKS’) disNam =’stock’; if($ (‘#impact_option’).html()==’MUTUAL FUNDS’) disNam =’mutual fund’; if($ (‘#impact_option’).html()==’COMMODITIES’) disNam =’commodity’; 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’); //$ (‘#mcpcp_addportfolio .form_field input, .form_field select, .form_btn input’).attr(‘disabled’, false); // //if(call_pg == “2”) //{ // adtxt =’ Scheme added to your portfolio We recommend you add transactional details to evaluate your investment better. x‘; //} //else //{ // adtxt =’ Stock added to your portfolio We recommend you add transactional details to evaluate your investment better. x‘; //} //$ (‘#mcpcp_addprof_info’).css(‘background-color’,’#eeffc8′); //$ (‘#mcpcp_addprof_info’).html(adtxt); //$ (‘#mcpcp_addprof_info’).show(); glbbid=v.id; } }); } }); } else { AFTERLOGINCALLBACK = ‘pcSavePort(‘+param+’, ‘+call_pg+’, ‘+dispId+’)’; commonPopRHS(); /*work_div = 1; typparam = t; typparam1 = n; check_login_pop(1)*/ } } function commonPopRHS(e) { /*var t = ($ (window).height() – $ (“#” + e).height()) / 2 + $ (window).scrollTop(); var n = ($ (window).width() – $ (“#” + e).width()) / 2 + $ (window).scrollLeft(); $ (“#” + e).css({ position: “absolute”, top: t, left: n }); $ (“#lightbox_cb,#” + e).fadeIn(300); $ (“#lightbox_cb”).remove(); $ (“body”).append(”); $ (“#lightbox_cb”).css({ filter: “alpha(opacity=80)” }).fadeIn()*/ $ (“#myframe”).attr(‘src’,’https://accounts.moneycontrol.com/mclogin/?d=2′); $ (“#LoginModal”).modal(); } function overlay(n) { document.getElementById(‘back’).style.width = document.body.clientWidth + “px”; document.getElementById(‘back’).style.height = document.body.clientHeight +”px”; document.getElementById(‘back’).style.display = ‘block’; jQuery.fn.center = function () { this.css(“position”,”absolute”); var topPos = ($ (window).height() – this.height() ) / 2; this.css(“top”, -topPos).show().animate({‘top’:topPos},300); this.css(“left”, ( $ (window).width() – this.width() ) / 2); return this; } setTimeout(function(){$ (‘#backInner’+n).center()},100); } function closeoverlay(n){ document.getElementById(‘back’).style.display = ‘none’; document.getElementById(‘backInner’+n).style.display = ‘none’; } stk_str=”; stk.forEach(function (stkData,index){ if(index==0){ stk_str+=stkData.stockId.trim(); }else{ stk_str+=’,’+stkData.stockId.trim(); } }); $ .get(‘//www.moneycontrol.com/techmvc/mc_apis/stock_details/?sc_id=’+stk_str, function(data) { stk.forEach(function (stkData,index){ $ (‘#stock-name-‘+stkData.stockId.trim()+’-‘+article_id).text(data[stkData.stockId.trim()][‘nse’][‘shortname’]); }); }); function redirectToTradeOpenDematAccountOnline(){ if (stock_isinid && stock_tradeType) { window.open(`https://www.moneycontrol.com/open-demat-account-online?classic=true&script_id=$ {stock_isinid}&ex=$ {stock_tradeType}&site=web&asset_class=stock&utm_source=moneycontrol&utm_medium=articlepage&utm_campaign=tradenow&utm_content=webbutton`, ‘_blank’); } }
Indoco Remedies on Monday said its Hyderabad-based clinical research organisation AnaCipher has successfully undergone inspection by the US health regulator with no observations.
The US Food and Drug Administration (USFDA) inspected AnaCipher from September 12-16, 2022, Indoco Remedies said in a regulatory filing.
“The clinical phase of inspection covered three BA/BE (bioavailability/bioequivalence) studies submitted by clients to the USFDA and was successfully concluded with zero (Form) 483s,” it added.
As per USFDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Indoco Remedies’ Managing Director Aditi Kare Panandikar said this is the seventh successive USFDA inspection with zero Form 483s for AnaCipher clinical research organisation (CRO).
AnaCipher CRO facility is spread over 40,000 square feet area with 98 beds. It conducts BA/BE studies. The CRO has successfully completed more than 500 studies in multiple therapeutic areas such as, cardiovascular, diabetes, oncology, antiretrovirals and antacids, the company said.
The CRO also has expertise in bioanalytical work for new chemical entities (Phase I-III studies) for pharmaceutical companies globally, it added.
