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Business Standard
30-06-2025
- 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
30-06-2025
- 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
30-06-2025
- 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
