News about Regulation

IPC Signs MoUs with PMBI and NIPER Hajipur to Enhance Drug Quality and Safety

IPC Signs MoUs with PMBI and NIPER Hajipur to Enhance Drug Quality and Safety

IPC signs MoUs with PMBI and NIPER Hajipur to enhance drug quality, pharmacovigilance, research, safety of biologics and emerging therapies, and patient safety across India, including Jan Aushadhi Kendras.

Regulation | 27/04/2026 | By News Bureau

US Food and Drug Administration Extends Review Timeline for Sarclisa Subcutaneous Formulation

US Food and Drug Administration Extends Review Timeline for Sarclisa Subcutaneous Formulation

FDA extends review timeline for Sanofi’s Sarclisa subcutaneous formulation, a potential first-in-class on-body injector therapy for multiple myeloma patients.

Regulation | 23/04/2026 | By News Bureau

Supriya Lifescience Receives US FDA EIR with VAI Status for Lote Parshuram Facility

Supriya Lifescience Receives US FDA EIR with VAI Status for Lote Parshuram Facility

Supriya Lifescience receives US FDA EIR with VAI classification for its Lote Parshuram facility, closing the February 2026 audit inspection cycle.

Regulation | 23/04/2026 | By News Bureau

National Pharmaceutical Pricing Authority Seeks Pricing Data for Gentamicin Formulation to Revise Ceiling Prices

National Pharmaceutical Pricing Authority Seeks Pricing Data for Gentamicin Formulation to Revise Ceiling Prices

NPPA directs companies to submit October 2023 pricing and turnover details for Gentamicin formulation as part of the updated price control framework under DPCO.

Regulation | 21/04/2026 | By News Bureau

Lupin Subsidiary Settles US Antitrust Case with Humana

Lupin Subsidiary Settles US Antitrust Case with Humana

Lupin subsidiary Lupin Pharmaceuticals Inc has reached a USD 30 million settlement with Humana in a US antitrust case, resolving claims without any admission of liability.

Regulation | 17/04/2026 | By News Bureau

Aurobindo Pharma Secures US FDA Approval for Glycerol Phenylbutyrate Oral Liquid 1.1 g/mL

Aurobindo Pharma Secures US FDA Approval for Glycerol Phenylbutyrate Oral Liquid 1.1 g/mL

Aurobindo Pharma has secured USFDA approval for Glycerol Phenylbutyrate Oral Liquid 1.1 g/mL, to be manufactured at its Unit-III facility, with immediate launch planned to strengthen its specialty pharma portfolio.

Regulation | 17/04/2026 | By News Bureau

India Pharma 2026: Policy Push and Innovation Fuel Pharmaceutical Industry Growth

India Pharma 2026: Policy Push and Innovation Fuel Pharmaceutical Industry Growth

9th India Pharma highlights policy support and innovation as key drivers of growth, with leaders emphasising biosimilars, specialty medicines and stronger industry-academia collaboration.

Regulation | 14/04/2026 | By News Bureau 222

Piramal Pharma Completes US FDA Inspection at Lexington Facility

Piramal Pharma Completes US FDA Inspection at Lexington Facility

Piramal Pharma receives US FDA EIR with VAI status for its Lexington facility, marking successful closure of inspection and regulatory compliance.

Regulation | 13/04/2026 | By News Bureau 153

Emalex Secures US Patent for Ecopipam ODT

Emalex Secures US Patent for Ecopipam ODT

Emalex secures a US composition-of-matter patent for its orally disintegrating ecopipam formulation, advancing drug development and expanding patient access.

Regulation | 10/04/2026 | By News Bureau 139

European Medicines Agency Recommends Ending Use of Tecovirimat SIGA for Mpox Treatment

European Medicines Agency Recommends Ending Use of Tecovirimat SIGA for Mpox Treatment

CHMP review finds no clinical benefit in mpox patients, while other approved uses of the antiviral remain unaffected.

Regulation | 30/03/2026 | By News Bureau 185

 
 

 

 

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