Gland Pharma facility in Vizag recieves EIR from U.S. FDA
Gland Pharma's facility in Visakhapatnam, which was earlier this year issued Form 483 with three observations by the U.S. Food and Drug Administration, has since received an establishment inspection report from the agency, the generic injectable focussed company said on Tuesday, a development that saw its shares close 1.43% higher at ₹1,768.75 apiece on the BSE.
The receipt of the EIR indicates closure of the U.S. FDA inspection conducted in February, the company said in a filling.
A pre-approval inspection (PAI) for sterile active pharmaceutical ingredients (APIs), the U.S. FDA had inspected the facillity from February 19-25 and on conclusion issued a Form 483 with three observations. The company had then said the observations are procedural in nature and it will submit the corrective and preventive actions to the agency within the stipulated period. The observations issued are neither repeated observations nor related to data integrity, Gland Pharma had said.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Mint
2 hours ago
- Mint
HDB Financial Services IPO: HDFC Bank's arm raises ₹3,369 crore from anchor investors ahead of public issue
HDB Financial Services IPO: India's largest private bank, HDFC Bank's subsidiary, HDB Financial Services, completed its anchor round on Tuesday, 24 June 2025. According to an exchange filing, the non-banking financial company (NBFC) raised ₹ 3,369 crore from anchor investors ahead of the public issue. According to the BSE filing, HDB Financial Services allotted a total of 4,55,27,026 or over 4.55 crore equity shares to the anchor investors at an allocation price of ₹ 740 per share with a face value of ₹ 10 apiece. BlackRock, Government Pension Fund Global, Goldman Sachs, Life Insurance Corp. of India (LIC), ICICI Prudential Mutual Fund, SBI Mutual Fund, Nippon India, Kotak Mutual Fund, Axis Mutual Fund, Fidelity Investments, Abu Dhabi Investment Authority, and HSBC are among the top anchor investors who participated in the anchor round of the HDB Financial Services IPO. LIC at 6.53%, followed by Baillie Gifford Pacific Fund at 3.09%, and Government Pension Fund Global at 2.97% were among the top allotments for the anchor round. Out of the total equity share allocation to the anchor investors, the company allocated 1,93,89,500 or more than 1.93 crore shares to 22 domestic mutual funds that applied for the public issue via 65 schemes. 'On the valuation front, at a higher price band, the issue is priced at P/BV 3.5x post-issue net worth. The issue seems to be fully priced given the business's fundamentals and ROE of ~15%. Though the company may benefit from the strong HDFC brand going forward,' said Mirae Asset Capital Markets in an IPO note. As of Tuesday, 24 June 2025, the grey market premium (GMP) of the HDB Financial Services IPO stood at ₹ 74 per share. With the upper price band at ₹ 740 apiece, the shares are expected to be listed at ₹ 814 per share, marking a listing premium of 10%, according to Investorgain data. Grey market premium (GMP) is an indicator of the investors' willingness to subscribe to a primary issue. The GMP jumped to its current level of ₹ 74 after the anchor round announcement on Tuesday, compared to its earlier level of ₹ 66 per share on Monday, 23 June 2025. HDB Financial Services is offering a fresh issue of equity shares amounting to ₹ 2,500 crore along with an offer-for-sale (OFS) component of ₹ 10,000 crore from the parent company HDFC Bank. The IPO is scheduled to open for public bidding on Wednesday, 25 June 2025, and will close on Friday, 27 June 2025. The company fixed the price band for the public issue in the range of ₹ 700 to ₹ 740 per share with a lot size of 20 equity shares per lot. HDB Financial aims to use the net proceeds from the public issue to strengthen the company's Tier-I Capital base, enabling the firm to meet forthcoming capital requirements across its business sectors, such as Enterprise Lending, Asset Finance, and Consumer Finance. JM Financial Limited, BNP Paribas, Bofa Securities India Limited, Goldman Sachs (India) Securities Private Limited, HSBC Securities & Capital Markets Pvt Ltd, IIFL Capital Services Limited, Jefferies India Private Limited, Morgan Stanley India Company Pvt Ltd, Motilal Oswal Investment Advisors Limited, Nomura Financial Advisory And Securities (India) Pvt Ltd, Nuvama Wealth Management Limited, and UBS Securities India Private Limited are the book-running lead managers for the public issue, while MUFG Intime India Private Limited (Link Intime) is the registrar to the offer. Read all stories by Anubhav Mukherjee
Time of India
2 hours ago
- Time of India
Hindalco to buy US-based AluChem for $125 mn
Hindalco Industries will acquire US-based specialty alumina manufacturer AluChem Companies for an enterprise value of $125 million, as it looks to scale its high-value, technology-led materials portfolio. "This acquisition is an important step in our global strategy to build a leadership position in value-added, high-tech materials," Kumar Mangalam Birla, chairman of the Aditya Birla Group said on Tuesday. The buyout is expected to be completed over the next two-four months, and will be funded through cash. The acquisition will be carried out through Aditya Holdings LLC , a stepdown wholly owned subsidiary of Hindalco. Hindalco-the world's largest aluminium company by revenue -is eyeing up to two-fifth of its earnings before interest, tax, depreciation and amortisation from downstream operations over the next three-four years, chief executive officer Satish Pai had said in March. The Aditya Birla Group company currently gets 10% of its Ebitda from downstream operations. "We had said that we are going to focus on our specialty alumina business that's been growing at double digits for the last five years, so this acquisition is a part of that strategy, especially for the technology part," Pai told ET exclusively on Tuesday. Hindalco has specialty alumina capacity of 500,000 tonne, and it plans to get to 1 million tonne over the next few years, Pai said. Specialty alumina finds application across electric mobility, semiconductors, and precision ceramics, and this buyout is expected to be highly value-accretive for the company. AluChem had an Ebitda of $381 per tonne in calendar year 2024 as compared to Hindalco's specialty alumina Ebitda of a little under $200 per tonne in fiscal 2025, Pai said. Total Ebitda from the specialty Alumina business was ₹835 crore last fiscal.
Mint
3 hours ago
- Mint
HDB Financial Services IPO: HDFC Bank arm raises ₹3,369 crore from anchor investors ahead of public issue
HDB Financial Services IPO: India's largest private bank, HDFC Bank's subsidiary, HDB Financial Services, completed its anchor round on Tuesday, 24 June 2025. According to an exchange filing, the non-banking financial company (NBFC) raised ₹ 3,369 crore from anchor investors ahead of the public issue. According to the BSE filing, HDB Financial Services allotted a total of 4,55,27,026 or over 4.55 crore equity shares to the anchor investors at an allocation price of ₹ 740 per share with a face value of ₹ 10 apiece. BlackRock, Government Pension Fund Global, Goldman Sachs, Life Insurance Corp. of India (LIC), ICICI Prudential Mutual Fund, SBI Mutual Fund, Nippon India, Kotak Mutual Fund, Axis Mutual Fund, Fidelity Investments, Abu Dhabi Investment Authority, and HSBC are among the top anchor investors who participated in the anchor round of the HDB Financial Services IPO. Out of the total equity share allocation to the anchor investors, the company allocated 1,93,89,500 or more than 1.93 crore shares to 22 domestic mutual funds that applied for the public issue via 65 schemes. HDB Financial Services is offering a fresh issue of equity shares amounting to ₹ 2,500 crore along with an offer-for-sale (OFS) component of ₹ 10,000 crore from the parent company HDFC Bank. The IPO is scheduled to open for public bidding on Wednesday, 25 June 2025, and will close on Friday, 27 June 2025. The company fixed the price band for the public issue in the range of ₹ 700 to ₹ 740 per share with a lot size of 20 equity shares per lot. HDB Financial aims to use the net proceeds from the public issue to strengthen the company's Tier-I Capital base, enabling the firm to meet forthcoming capital requirements across its business sectors, such as Enterprise Lending, Asset Finance, and Consumer Finance. JM Financial Limited, BNP Paribas, Bofa Securities India Limited, Goldman Sachs (India) Securities Private Limited, HSBC Securities & Capital Markets Pvt Ltd, IIFL Capital Services Limited, Jefferies India Private Limited, Morgan Stanley India Company Pvt Ltd, Motilal Oswal Investment Advisors Limited, Nomura Financial Advisory And Securities (India) Pvt Ltd, Nuvama Wealth Management Limited, and UBS Securities India Private Limited are the book-running lead managers for the public issue, while MUFG Intime India Private Limited (Link Intime) is the registrar to the offer. Read all stories by Anubhav Mukherjee Disclaimer: This story is for educational purposes only. The views and recommendations above are those of individual analysts or broking companies, not Mint. We advise investors to check with certified experts before making any investment decisions.
