Latest news with #cGMP
Business Standard
3 days ago
- Business
- Business Standard
Marksans Pharma rises after subsidiary gets EIR for New York-based facility from US FDA
Marksans Pharma advanced 1.86% to Rs 257 after the company's subsidiary Time-Cap Laboratories Inc. has received the establishment inspection report from the US FDA for its manufacturing facility based in New York. In April this year, the United States Food and Drug Administration (US FDA) had conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of Time-Cap Laboratories, Inc. located at Michael Avenue, Farmingdale, New York, USA. The inspection was conducted between 16th and 24th of April 2025. Post the said inspection, the American drug regulator had issued one inspectional observation in Form 483. There was no data integrity observation. In a regulatory filing made during market hours today, Marksans Pharma stated that Time-Cap Laboratories has received the establishment inspection report (EIR) from the US FDA for the said facility. Marksans Pharma is engaged in research, manufacturing & marketing of generic pharmaceutical formulation in the global markets. The company's manufacturing facilities located in India, USA and UK are approved by several leading regulatory agencies, including USFDA, UKMHRA and Australian TGA. The company's robust product portfolio spreads over major therapeutic segments of CVS, CNS, anti-diabetic, pain management, gastroenterological, and antiallergic. The company is marketing these products globally. The company reported a 15.7% increase in consolidated net profit to Rs 90.55 crore on a 26.5% rise in revenue from operations to Rs 708.46 crore in Q4 FY25 over Q4 FY24.
Business Standard
3 days ago
- Business
- Business Standard
Time-Cap Laboratories successfully concludes USFDA inspection
Marksans Pharma announced that its subsidiary, Time-Cap Laboratories Inc. has received the Establishment Inspection Report from USFDA. The USFDA had conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of the Company's wholly owned subsidiary Time-Cap Laboratories, Inc. located at Farmingdale, New York, USA from 16 April 2025 to 24 April 2025.
Business Upturn
3 days ago
- Business
- Business Upturn
Marksans Pharma receives EIR from USFDA for Time-Cap Labs facility
By Aman Shukla Published on June 30, 2025, 12:33 IST Marksans Pharma has announced a positive update regarding its US operations. The company shared that its wholly owned subsidiary, Time-Cap Laboratories Inc., based in Farmingdale, New York, has successfully received the Establishment Inspection Report (EIR) from the USFDA. This follows a routine cGMP (current Good Manufacturing Practices) inspection that took place from April 16 to April 24, 2025. The inspection covered the site's compliance with quality standards, and the EIR indicates a satisfactory outcome. For those unfamiliar, Marksans Pharma is a Mumbai-headquartered pharmaceutical company that specializes in research, manufacturing, and global marketing of generic medicines. Its facilities are approved by top global regulators like the USFDA, UKMHRA, and Australia's TGA. The company's product lineup spans key therapeutic areas, including cardiovascular, central nervous system, diabetes care, pain relief, gastrointestinal health, and allergy treatment—and it's actively selling these in markets around the world. This USFDA approval reinforces Marksans Pharma's commitment to maintaining high-quality standards and its steady expansion in regulated markets. 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
The Hindu
5 days ago
- Health
- The Hindu
Aurobindo recalling over 4,600 bottles of pain relieving tablets in U.S.
Generic drugmaker Aurobindo Pharma is recalling 4,608 bottles of pain relieving drug Acetaminophen Tablets, 325 mg, in the U.S. They are 100-count bottles and being recalled due to deviations from current Good Manufacturing Practices (cGMP), the U.S. Food and Drug Administration (U.S. FDA) said. Specially it is 'due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets),' the regulator said in its latest enforcement report. It is a voluntary recall and initiated by Aurobindo Pharma USA Inc., a subsidiary of the Hyderabad-based drugmaker, on May 22.
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Business Standard
6 days ago
- Business
- Business Standard
Aurobindo Pharma recalls over 4,600 bottles of painkiller in US market
Aurobindo Pharma's United States unit has initiated a recall of more than 4,600 bottles of a pain relief medication from the American market following consumer complaints about product quality, according to the US Food and Drug Administration's (USFDA) Enforcement Report. The product — Acetaminophen Tablets (325 mg) — is being recalled due to manufacturing deviations from Current Good Manufacturing Practices (cGMP), triggered by 'confirmed consumer complaints received with the observation of tablet discolouration (brown surface on tablets)', the US drug regulator mentioned. The Class-II recall of the drug, which is generally used for the relief of headaches, migraine, back pain, toothache, and muscular pain, was initiated by the Princeton-based subsidiary on May 22, the report mentioned. As per the USFDA classification, a Class-II recall is initiated 'when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the probability of serious adverse health consequences is remote.' Reason for recall cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets) Product quantity 4,608 bottles Classification Class-II Aurobindo Pharma Q4 results In the fourth quarter of financial year 2024–25 (Q4FY25), Aurobindo Pharma Limited reported a marginal slump of 0.5 per cent in its net profit to ₹903 crore, compared to ₹907 crore in the same period last year. However, the revenue from operations hiked 10.6 per cent year-on-year (Y-o-Y) to ₹8,382 crore during the quarter, with growth seen across key business segments. Revenue from US formulations grew by 13.5 per cent Y-o-Y to ₹4,072 crore ($470 million), while Europe formulations posted a stronger growth of 17.2 per cent Y-o-Y to ₹2,147 crore (€236 million). Shares of Aurobindo Pharma last traded at ₹1124.75 apiece on the BSE at the close of the markets on Friday.
