Industry News

Novavax, Inc a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the worlds largest vaccine manufacturer by volume, announced that the Drugs Controller General of India has granted emergency use authorization (EUA) for Novavax protein-based COVID-19 vaccine for adolescents aged ≥12 to <18 years in India.

Bharat Biotech has entered into a partnership with Biofabri, a Spanish biopharmaceutical firm, for the development, manufacturing and marketing of a new tuberculosis vaccine. This partnership will guarantee the supply of TB vaccines in more than 70 countries especially in Southeast Asia, and sub-Saharan Africa with a high TB incidence.

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