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Business Standard
5 days ago
- Business
- Business Standard
Gland Pharma jumps 3% in trade; here's what is boosting investor interest
Gland Pharma shares gained 3.2 per cent in trade on Tuesday, logging an intraday high at ₹1,800 per share on BSE. The stock was in demand after the company received an Establishment Inspection Report (EIR) from the US Food and Drugs Administration (US FDA) for its facility at JNPC, Visakhapatnam. At 12:12 PM, Gland Pharma share price was trading 2.08 per cent higher at ₹1,780 per share on the BSE. In comparison, the BSE Sensex was up 1.34 per cent at 82,993.55. The company's market capitalisation stood at ₹29,326.64 crore. Its 52-week high was at ₹2,220.95 per share and 52-week low was at ₹1,200 per share. "This is to inform you that following the Pre-approval inspection (PAI) for Sterile APIs at the Company's Facility at JNPC, Visakhapatnam between February 19, 2025, and February 25, 2025; the Company has received an Establishment Inspection Report (EIR) from the US FDA indicating closure of the inspection," the filing read. EIR is a document generated by the US FDA or other regulatory authorities after they conduct an inspection of a pharmaceutical manufacturing facility. The EIR serves as an official record of the company's compliance with Good Manufacturing Practices (GMP), safety protocols, and regulatory requirements. A positive EIR (indicating compliance) shows that the company meets the necessary standards to produce drugs safely and effectively. Recently, Gland Pharma secured USFDA approval for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection 2.5 mg/mL. Angiotensin II is a vasoconstrictor indicated for increasing blood pressure in adults with septic or other distributive shock. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Giapreza of La Jolla Pharma LLC, the company revealed. About Gland Pharma Gland Pharma is a small-molecule generic injectables-focused company, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets in the rest of the world. Gland Pharma has seven manufacturing facilities in India, comprising four facilities for finished formulations and three API facilities. We are focused on meeting diverse injectables needs with a stable supply of affordable and high-quality products. We have established a portfolio of injectables products across various therapeutic segments and delivery systems and are present in sterile injectables, oncology and ophthalmics with a focus on complex injectable
Business Upturn
5 days ago
- Business
- Business Upturn
Concord Biotech receives EIR from USFDA for Dholka API facility, no regulatory action required
Concord Biotech Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility located in Dholka, Gujarat. The inspection was conducted by the USFDA from April 28 to May 2, 2025. Following the detailed evaluation, the USFDA has formally concluded the inspection and issued the EIR, indicating that the facility meets the agency's standards of compliance. According to Concord Biotech, the inspection has been officially closed under 21 CFR 20.64(d)(3), confirming that no regulatory or corrective action is required. This positive outcome allows the company to continue operations at the Dholka site without any restrictions or compliance-related concerns. This development marks a crucial step in reinforcing Concord Biotech's reputation for maintaining high-quality manufacturing standards in line with global regulatory expectations Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Standard
5 days ago
- Business
- Business Standard
Gland Pharma gains after receiving EIR from USFDA for Visakhapatnam facility
Gland Pharma rose 1.62% to Rs 1,772 after the company announced that it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA), indicating the closure of the inspection at its Visakhapatnam facility. As per the exchange filing dated 25 February 2025, the USFDA had conducted a pre-approval inspection (PAI) for sterile APIs at the companys facility located at JNPC, Visakhapatnam, between 19 February and 25 February 2025. The inspection concluded with three Form 483 observations, which the company clarified were procedural in nature. The firm stated that these are not repeated observations and are unrelated to data integrity. The company intends to submit the required corrective and preventive actions (CAPA) to the USFDA within the stipulated timeline. Gland Pharma is one of the largest and fastest-growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered heparin technology in India. The company's consolidated net profit declined 3.06% to Rs 186.54 crore as net sales fell by 7.32% to Rs 1424.91 crore in Q4 FY25 as compared with Q4 FY24.
Business Upturn
5 days ago
- Business
- Business Upturn
Gland Pharma gets EIR from US FDA for Visakhapatnam JNPC facility
By Aman Shukla Published on June 24, 2025, 10:46 IST Gland Pharma has announced that it has received the Establishment Inspection Report (EIR) from the US FDA for its sterile API manufacturing facility located at JNPC, Visakhapatnam. This follows the successful completion of the Pre-Approval Inspection (PAI) conducted between February 19 and February 25, 2025. The receipt of the EIR indicates the closure of the inspection, signaling that the facility complies with the US FDA's regulatory requirements. This development marks a positive step forward for Gland Pharma's US operations and reinforces its commitment to maintaining high standards of quality and compliance. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Standard
18-06-2025
- Business
- Business Standard
Alembic Pharma receives USFDA EIR for Karakhadi API facility
Alembic Pharmaceuticals said that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API)-III facility in Karakhadi, Gujarat. The inspection was conducted at the API-III facility from 17th March 2025 to 21st March 2025. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24. Shares of Alembic Pharmaceuticals shed 0.78% to Rs 962.70 on the BSE.
