News about Global Pharma

USFDA Inspects Aurobindo Pharma's New Jersey-Based Facility,Issues 10 Observations

The United States Food and Drug Administration (USFDA) issued 10 observations after conducting a pre-approval inspection at a facility linked to wholly-owned arm of Aurobindo Pharma in New Jersey

Global Pharma | 26/12/2023 | By Manvi |  1053

Zydus Lifesciences Receives 6 Observations from USFDA for API Site at Changodar

The inspection closed with 6 observations. There were no Data Integrity related observations. There are no repeat observations from the previous inspection.

Global Pharma | 26/12/2023 | By Manvi |  643

AstraZeneca and Ionis' Wainua Granted First-Ever Regulatory Approval in US

AstraZeneca and Ionis’ Wainua (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. Wainua is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector.

Global Pharma | 26/12/2023 | By Manvi |  656

Thermo Fisher Scientific Announces Launch of Innovative CorEvitas Pharmacovigilance Platform

Thermo Fisher Scientific Inc. announced the launch of CorEvidence, a proprietary cloud-based data lake platform optimizing pharmacovigilance case processing and safety data management processes.

Global Pharma | 22/12/2023 | By Manvi |  786

Natco Pharma Ltd and Breckenridge Dismissed from Antitrust Lawsuit

The plaintiffs voluntarily dismissed Breckenridge Pharmaceutical Inc. and Natco Pharma Limited from the case.

Global Pharma | 22/12/2023 | By Manvi |  500

Venus Remedies Achieves Marketing Authorizations for Docetaxel in Israel and Cytarabine in Colombia

Venus Remedies announce dual achievements in securing marketing authorisations for three variants of Docetaxel in Israel and Cytarabjne 100MG in Colombia.

Global Pharma | 22/12/2023 | By Manvi |  657

Bain Capital-Backed Emcure Pharma Files Fresh IPO Papers with Sebi

Bain Capital-backed Emcure Pharmaceuticals has filed fresh preliminary papers with capital markets regulator Sebi to raise funds through an Initial Public Offering (IPO).

Global Pharma | 21/12/2023 | By Manvi |  1166

Tower Cold Chain Partnership Unveiled in China

Tower Cold Chain has reinforced its global availability by partnering with a Shanghai-based organisation, Tower & Winner Solutions (TWS), to drive the growth of Tower’s temperature-controlled passive containers across the Chinese market.

Global Pharma | 21/12/2023 | By Manvi |  499

Nirma Gets CCI Nod for Picking up Majority Stake in Glenmark Life Sciences

The Competition Commission of India (CCI) said it cleared Nirma’s acquisition of majority shareholding of Glenmark Life Sciences Ltd.

Global Pharma | 21/12/2023 | By Manvi |  648

Aurobindo Subsidiary in Tirupati Classified as VAI by US FDA

The inspection was conducted at Unit IV of APL Healthcare Limited, a wholly-owned subsidiary of the company, situated at Menakuru Village, under the Naidupeta Mandal, in Tirupati District of Andhra Pradesh.This is a formulation manufacturing facility.

Global Pharma | 21/12/2023 | By Manvi |  2081