Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
Sun Pharmaceutical Industries Ltd named Kamlesh H Shah company secretary. He replaces R K Baheti, who was also senior vice president (finance).
Sun Pharmaceutical said Ranbaxy shareholders will get 0.8 Sun Pharma shares for each Ranbaxy share.
Many say trend could lead to concerns on manufacturing quality in Indian facilities.
Sun Pharmaceutical Industries Ltd has informed BSE that a meeting of its board will be held on January 30 to take on record unaudited financial results of the company for the third quarter ended December 31.
Acquisition to boost its generics business in developed markets.
"Through this partnership, the reach of Sitagliptin and Sitagliptin plus Metformin will be enhanced amongst doctors and patients in India, helping them efficaciously manage the disease," Sun Pharma Chief Executive Officer Kalyanasundaram said in a joint statement issued by the two firms.
In May, Taro had unilaterally terminated $-454 million merger agreement signed between Taro and Sun Pharma in 2007, citing undervaluations of its shares. Thereafter, both companies had filed suits against each other in Israel and New York.
Sun Pharmaceutical Industries Ltd Chairman Dilip Shanghvi said he expects Ranbaxy Laboratories Ltd to become profitable in the short term.
Sun Pharmaceutical Industries Ltd has posted a net profit of Rs 558.60 million for the quarter ended December 31, 2002 as compared to a net profit of Rs 464.10 million in the corresponding period last fiscal.
Sun Pharmaceutical Industries Ltd on Monday said its Michigan-based wholly owned subsidiary,
Sun Pharmaceutical Industries Ltd has entered into an agreement with two large shareholders of its subsidiary Caraco Pharmaceutical Laboratories Ltd to acquire most of their common stock and options in the latter for $42 million.
Sun Pharmaceuticals Industries Ltd has posted a 45.01 per cent rise in its consolidated net profit at Rs 358.9 crore (Rs 3.59 billion) for the financial year 2003-04 as against Rs 247.5 crore (Rs 2.47 billion) in 2002-03.
Sun Pharmaceutical Industries Ltd has posted a 47.24 per cent rise in consolidated net profits at Rs 247.5 crore (Rs 2.47 billion) in the financial year ended March 31, 2003, compared to Rs 168.09 crore (Rs 1.68 billion).
Both companies can now complete the deal.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.
Ranbaxy drugs sold in the United States will be gradually rebranded as Sun Pharma treatments
The deal will provide Suzlon with much needed liquidity.
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.
Two individuals filed the petition in the high court of Andhra Pradesh
Daiichi won't remain a major shareholder in Sun Pharma.
Rosier year-end seen for Indian pharma thanks to faster US approvals.
Credit Suisse analysts cut their rating on Sun Pharma stock to 'neutral' from 'outperform
Data late on Wednesday showed consumer price inflation eased more than-expected to a 25-month low of 8.10 per cent in February, while industrial output unexpectedly expanded, albeit only by 0.1 per cent.
Is yet to decide about the partnership or acquisition route
Sun Pharma open to large acquisitions post Ranbaxy.
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
The FDA has stepped up its efforts to ensure drug safety in recent months.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
Sun Pharmaceutical's acquisition of Ranbaxy has received final approvals.
Some Indian generic drugmakers are, however, uncertain about the pace of approvals in the near future.
Mergers are not just about balance sheets or marketing synergies; they are also about those who make the synergies real.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
Dhirubhai Ambani lived in a one-room chawl in Mumbai with his wife and children and went on to establish the Reliance Group.
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