NSE-listed pharmaceutical companies with US FDA-approved manufacturing facilities and active ANDA filing pipelines, positioned to benefit from India's surging regulated-market pharma export growth.
Sectors represented: Healthcare
Bhagwan Chodhary: And what is the update on this US FDA inspection part?. Adhish Patil: So we furnished the final response in the month of September. And then in October, for the. same plant, we got EDQM audit. t is the update on this US FDA inspection part?. Adhish Patil: So we furnished the final response in the month of September. And then in October, for the. same plant, we got EDQM audit.
In-house analytical and. characterization capabilities. for drug-device. combinations. . USFDA inspection in Oct-. Nov 2023, EIR received in. Dec 2023. > 190 scientists and 29. regulatory affairs. professionals in a matrix. structure. 1. Experienced R&D team in. developing regulatory strategy ns. . USFDA inspection in Oct-. Nov 2023, EIR received in. Dec 2023. > 190 scientists and 29.
Active pharmaceutical ingredients Production. Facility. USFDA (US), DMA (Denmark). 3233. GLAND PHARMA LIMITED. Annual Report 2022-23. Corporate OverviewStatutory ReportsFinancial Statements. 6-5758-142143-268 ive pharmaceutical ingredients Production. Facility. USFDA (US), DMA (Denmark). 3233. GLAND PHARMA LIMITED. Annual Report 2022-23. Corporate OverviewStatutory ReportsFinancial Statements.
In FY2025, the Company generated ₹24,818 million in revenue. from the US market, marking a 10.4% year-on-year decrease. This de-growth was primarily driven by pricing pressure in. existing portfolio and absence of meaningful launches. Key Highlights:. `24,818 million the US market, marking a 10.4% year-on-year decrease. This de-growth was primarily driven by pricing pressure in.
The CMO and Allergy Immunotherapy Business Units, based in the Spokane. facility, were inspected by the US FDA’s Centre for Biologics Evaluation and. Research (CBER) and the Centre for Drug Evaluation and Research (CDER). Immunotherapy Business Units, based in the Spokane. facility, were inspected by the US FDA’s Centre for Biologics Evaluation and.
One of them is a combination. product which was filed after. successful completion of large scale. multicentric clinical trials. Cipla was. the first generic filer for another. breath actuated inhaler product. To build robust pipeline in oncology,. in FY 2023-24, we filed three. products in US. scale. multicentric clinical trials. Cipla was. the first generic filer for another.
Tablets, Cetirizine Tablets, Pregabalin Capsules and one tentative approval for ANDA for Canagliflozin. & Metformin HCl Tablets. Lofexidine Tablets ANDA was the First Generic in the US market, for which. Indoco received 180 days exclusivity. Capsules and one tentative approval for ANDA for Canagliflozin. & Metformin HCl Tablets.
July 2019. (1)As of March31, 2022 any). Last USFDA audit successfully. completed and EIR received in. September 2019. CHENNAI. TAMIL NADU. USFDA audit with Establishment. Inspection Report (EIR) received in. July 2019. (1)As of March31, 2022. KOTHUR. TELANGANA. Oral and solid dosages. including cytotoxic Orals. and cytotoxic injectables. USFDA, GMP, (DCA),. German, Health Authority,.
Enteredintoanews e g m e ntofAPI with. acquisitionofRatnageneLifesciencePvt.Ltd. 1. 2021. 2021. 2023. 2023. 2024. Successful Listing on Stock. Exchanges in India on BSE & NSE. 16. 2025 FDA approvedfacilityinUS. Enteredintoanews e g m e ntofAPI with. acquisitionofRatnageneLifesciencePvt.Ltd. 1. 2021. 2021. 2023. 2023. 2024. Successful Listing on Stock. Exchanges in India on BSE & NSE. 16. 2025.
United States Attorney’s Office for the District of New Jersey (US DOJ) had also issued an administrative subpoena,. dated March 13, 2014, seeking information. The Company has fully cooperated and provided the requisite information. to the US DOJ. ct of New Jersey (US DOJ) had also issued an administrative subpoena,. dated March 13, 2014, seeking information.
Cardiovascular drugs. 1. 2022 saw a growing share of first-in-class medicines and. continued growth in number of specialty medicine launches. While the value and volume of the market grew, 2022 saw fewer. approvals of new drugs by the U.S. Food and Drug Administration. (USFDA). A total of 37 new drugs were approved in 2022,. compared to 50 in 2021. and volume of the market grew, 2022 saw fewer.
Meanwhile, the Gagillapur site had received a GMP certificate from the German authorities, an. outcome of the inspection completed in February '25. The site had also completed eight customer. audits with no critical observations, and received the UL certificate last quarter. man authorities, an. outcome of the inspection completed in February '25. The site had also completed eight customer.
Finance Cost#2.1%1.1%0.8%4.0%5.3%. Income on investments. in INR (cumulative for. the period). 35.0148.5209.6. ParticularsQ3FY24. Cash Flow from Business after working capital & Others. 45. Less: Capex Normal/ANDA. -52 st#2.1%1.1%0.8%4.0%5.3%. Income on investments. in INR (cumulative for. the period). 35.0148.5209.6. ParticularsQ3FY24. Cash Flow from Business after working capital & Others. 45.
Overall FY23 grew +25%. Driven by unprecedented growth in the CDMO business further boosted. by improvement in production downtime. New Capacity implemented at R2 in the ramp up phase and further. expect debottlenecking to complete in next 3-4 months. Enhanced technical expertise in bio-enzyme catalysis to promote. application in small molecule commercial DS projects/explore new.
Formulation. facility. 1907. Established by. AminFamily. FDA approved. API facility. 2006. Acquired Dabur’s. Indian Cardiology,. GI and Gynecology. brands. 2007. 2008. FDA approved. Formulation facility. Multiple divisions to. address chronic. therapies launched. 2009. 2010. Formed a JV,. Rhizen, for NCE. Research. 2012. Pharmaceutical. business demerged. from Alembic. Group. 2013. 2015. 2016.