Industry News

Granules India ltd has received a license from Medicines Patent Pool (MPP) to manufacture and market generic versions of Pfizer’s oral treatment nirmatrelvir which will be copackaged with ritonavir for treatment of COVID-19. The licenses are applicable for both active pharmaceutical ingredients (API) and finished products, in tablet form, of nirmatrelvir; ritonavir.

Granules India Limited, announced that Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, located in Chantilly, Virginia, USA received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA).

The GPI facility was inspected by the US FDA from 24th to 28th January 2022 for two of its product applications filed. There were three minor observations during the inspection and GPI had addressed the observations in the stipulated time period.

Indian pharmaceutical companies may replace western manufacturers leaving the Russian market, Russian envoy to India Denis Alipov said.

"The withdrawal of many Western companies from the Russian market and those niches that have been vacated may actually be occupied by Indian companies in many industries, in particular, in pharmaceuticals," Alipov told the Rossiya 24 broadcaster, as quoted by Sputnik news agency.

Zydus Lifesciences Ltd has received final approval from the USFDA to market Colestipol Hydrochloride Tablets in the strength of 1mg (US RLD: Colestid). Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet.

Colestipol Hydrochloride is a highly complex macro molecule drug substance with little or no systemic absorption.

The SMILE-100 System is a breast thermography device that helps healthcare personnel to review, measure and analyse thermally significant indications in the breast region

Sentynl Therapeutics, Inc. (Sentynl), a U.S. based biopharmaceutical company and a wholly owned subsidiary of Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), focused on bringing innovative therapies to patients living with rare diseases and BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, today announced the execution of an asset purchase agreement (the Agreement) for the sale of BridgeBio’s NULIBRY (Fosdenopterin) for Injection.

Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/gram. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 U/g/0.1%, of Taro Pharmaceuticals U.S.A. Inc. Nystatin and Triamcinolone

Biotechnology company Zymergen is pleased to announce early results from its work on infectious disease, discovering hundreds of potential novel hits against malaria, tuberculosis, and COVID-19 targets. Hits for PfAPP, a critical target in the treatment of malaria, are now being advanced for validation, with hits for an emerging COVID-19 target, PLpro, expected to follow.

Zydus Lifesciences Ltd a discovery-driven, global lifesciences company announced that it has received approval for its New Drug Application (NDA) from the Drug Controller General of India for OxemiaTM (Desidustat), a first-of-its-kind oral treatment in India for anemia associated with Chronic Kidney Disease (CKD).