Latest news with #EstablishmentInspectionReport
Business Standard
3 days ago
- 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.
Business Upturn
3 days ago
- Business
- Business Upturn
Alembic Pharma receives EIR from USFDA for Karakhadi API-III facility
By Aman Shukla Published on June 18, 2025, 12:12 IST Alembic Pharmaceuticals has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API-III manufacturing facility located in Karakhadi, Gujarat. The inspection was conducted between March 17 and March 21, 2025. The successful completion of the USFDA inspection and receipt of the EIR marks a significant regulatory milestone for Alembic, reinforcing the company's compliance with global quality standards. The API-III facility plays a key role in the production of active pharmaceutical ingredients (APIs) for Alembic's global markets. This development is expected to strengthen Alembic's position in the US market and support its ongoing growth in international formulations and API exports. In the meantime, Alembic Pharmaceuticals shares opened at ₹969.00 on Wednesday, and, at the time of writing, reached a high of ₹974.20 and a low of ₹953.10 during intraday trading. The stock remains significantly below its 52-week high of ₹1,303.90 but well above the 52-week low of ₹725.20. 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
Economic Times
5 days ago
- Business
- Economic Times
Syngene International shares in focus after positive USFDA updates for 2 Bengaluru facilities
Syngene International shares: The company received two important updates from the U.S. Food and Drug Administration (USFDA). Syngene International shares:The initial update concerns a Good Clinical Practices (GCP) compliance inspection carried out at Syngene's Semicon Park facility in Bengaluru between June 9 and June 13, 2025. The inspection resulted in no findings, and no Form 483 was issued. It was classified as 'No Action Indicated' (NAI), indicating full adherence to regulatory standards. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Shares of Syngene International are expected to be in focus on Monday, June 16, 2025, after the company received two significant updates from the United States Food and Drug Administration (USFDA) concerning inspections at its facilities in first update relates to a Good Clinical Practices (GCP) compliance inspection conducted at Syngene's Semicon Park facility, Bengaluru, from June 9 to June 13, 2025. The inspection concluded with zero observations, and no Form 483 was issued. The inspection was classified as 'No Action Indicated' (NAI), signifying full compliance with regulatory a separate development, the USFDA also concluded its review of an earlier inspection held between February 10 and February 20, 2025, at Syngene's GMP manufacturing facilities in Biocon Park, SEZ, Bengaluru. The company received the Establishment Inspection Report (EIR) on June 11, 2025. The inspection was classified as 'Voluntary Action Indicated' (VAI), and the USFDA has accepted Syngene's responses and Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional updates indicate regulatory progress and compliance, which could be seen positively by the company has stated that it will continue to provide periodic updates to the USFDA and remains committed to the highest standards of compliance. It also clarified that the inspection outcomes will not have any adverse impact on its financials or a separate regulatory filing, the company also confirmed the resignation of Ms. Priyadarshini Mahapatra from the position of Head Legal, Company Secretary & Compliance Officer, effective from the close of business hours on June 9, 2025. Her resignation was previously communicated on April 23, 2025. Syngene International shares closed 1.6% lower at Rs 652.50 on the BSE.: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
Time of India
6 days ago
- Business
- Time of India
Syngene International shares in focus after positive USFDA updates for 2 Bengaluru facilities
Shares of Syngene International are expected to be in focus on Monday, June 16, 2025, after the company received two significant updates from the United States Food and Drug Administration (USFDA) concerning inspections at its facilities in Bengaluru. The first update relates to a Good Clinical Practices (GCP) compliance inspection conducted at Syngene's Semicon Park facility, Bengaluru, from June 9 to June 13, 2025. The inspection concluded with zero observations, and no Form 483 was issued. The inspection was classified as 'No Action Indicated' (NAI), signifying full compliance with regulatory expectations. In a separate development, the USFDA also concluded its review of an earlier inspection held between February 10 and February 20, 2025, at Syngene's GMP manufacturing facilities in Biocon Park, SEZ, Bengaluru. The company received the Establishment Inspection Report (EIR) on June 11, 2025. The inspection was classified as 'Voluntary Action Indicated' (VAI), and the USFDA has accepted Syngene's responses and Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional findings. These updates indicate regulatory progress and compliance, which could be seen positively by the market. Also read: Bajaj Finance stock split, bonus issue: Here's how your 10 shares will turn into 100 Live Events The company has stated that it will continue to provide periodic updates to the USFDA and remains committed to the highest standards of compliance. It also clarified that the inspection outcomes will not have any adverse impact on its financials or operations. In a separate regulatory filing, the company also confirmed the resignation of Ms. Priyadarshini Mahapatra from the position of Head Legal, Company Secretary & Compliance Officer, effective from the close of business hours on June 9, 2025. Her resignation was previously communicated on April 23, 2025. Syngene International shares closed 1.6% lower at Rs 652.50 on the BSE. ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
Business Upturn
13-06-2025
- Business
- Business Upturn
Syngene International receives EIR from USFDA for Biocon Park facility, inspection concludes with VAI classification
Syngene International Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its GMP manufacturing facilities located at Biocon Park, SEZ, Bengaluru. This follows the routine current Good Manufacturing Practices (cGMP) inspection conducted between February 10 and February 20, 2025. As per the EIR dated June 11, 2025, the inspection has been classified as Voluntary Action Indicated (VAI). The USFDA has reviewed and accepted Syngene's responses along with the Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional observations. Advertisement The company will continue to provide periodic updates to the USFDA on the implementation status of the corrective actions. Syngene reiterates its commitment to maintaining the highest standards of regulatory compliance. This inspection outcome is not expected to have any adverse impact on the Company's financial performance or operations.
