USFDA successfully concludes inspection at Piramal Pharma USA facility

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-04-18 12:06 GMT | Update On 2024-04-18 12:06 GMT

Mumbai: Piramal Pharma Limited has informed through a recent BSE filing that the US Food and Drug ADministration (US FDA) has issued an Establishment Inspection Report (EIR) for the Riverview, USA manufacturing facility and the inspection has now been successfully closed by the US FDA.

Medical Dialogues team had earlier reported that the US FDA had concluded a Pre-Approval Inspection (PAI) with 3 observations at the Company's Riverview (USA) facility.

Piramal Pharma Limited (PPL) offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 15 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business, and the India Consumer Healthcare business selling over-the-counter products.

PPS offers end-to-end development and manufacturing solutions through a globally integrated network of facilities across the drug life cycle to innovators and generic companies. PCC’s complex hospital product portfolio includes inhalation anaesthetics, intrathecal therapies for spasticity and pain management, injectable pain and anaesthetics, injectable anti-infectives, and other therapies.

In addition, PPL has a joint venture with Allergan. In October 2020, the company received a growth equity investment from the Carlyle Group.

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

USFDA successfully concludes inspection at Piramal Pharma USA facility

Similar News

Lupin bags USFDA approval for Multiple myeloma treatment

Biocon Biologics wins USFDA nod for Bosaya and Aukelso, Denosumab Biosimilars

Cocrystals of Approved APIs to Be Treated as New Drugs, Clarifies CDSCO

India ranks among top global contributors in adverse event reporting: DCGI

Marketers Linked to Defaulting Pharma Units Under DCGI Lens

Intas Pharma Secures CDSCO Panel Approval for Post-Marketing Study of Tacrolimus Enema

Health Authorities Crack Down on OTC Sale of Antibiotics, NRx Drugs in Visakhapatnam

Merck gets USFDA Breakthrough Therapy Designation for Raludotatug deruxtecan for Platinum-Resistant Ovarian Cancer