Biocon shares fall 2% after Malaysia unit receives 6 observations from USFDA

The company to announce results for the quarter ended June on August 10, 2023.

‘);
$(‘#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=”;
let secglbVar = 1;
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 postfolio_url = ‘https://www.moneycontrol.com/portfolio_new/add_stocks_multi.php?id=’+dispId;
window.open(postfolio_url, ‘_blank’);
} 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()*/

$(“.linkSignUp”).click();
}

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/?classic=true&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’);
}
}

Biocon shares were down 2 percent to Rs 258.50 at 9.27am on Monday after the company received six observations from the US Food and Drug Administration (USFDA).

The US FDA conducted two cGMP inspections at Biocon Sdn. Bhd’s insulins manufacturing facility in Malaysia, encompassing biologics drug substance, drug product units and quality control laboratories, as well as the delivery devices unit.

These inspections were conducted between July 10 and 20. The agency has issued Form 483 with six observations for drug substance, drug product units and quality control laboratories as well as 2 observations for the delivery devices unit.

These observations primarily relate to enhancing the operational procedures and strengthening training programmes. The inspections did not identify any data integrity breaches or systemic non-compliance, the company said.

We will submit a Corrective and Preventive Action (CAPA) plan to the USFDA in a timely manner and are confident of addressing these observations expeditiously. Biocon Biologics remains committed to global standards of quality and compliance, it added

Catch all the market action on our live blog

The meeting of the board of directors of the company is scheduled on August 10 to approve and take on record the un-audited standalone and consolidated financial results for the quarter ended June 30, 2023, amongst other routine matters.

Subsidiary Biocon Biologics announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of YESAFILI, an aflibercept biosimilar.

The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected by the end of September 2023.