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  • Lupin receives warning letter from USFDA

    Lupin has received a warning letter from the USFDA for their Tarapur, Maharashtra facility. The U.S. FDA had inspected the Lupin Tarapur site from March 22, 2022 to April 4, 2022.

    Initially, USFDA has closed the inspection at Lupin’s Tarapur manufacturing facility with four observations.

  • Lupin Launches Sildenafil for Oral Suspension in the United States

    Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

  • Bayers Eylea approved in Japan for child ratinopathy

    Bayer announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Eylea (aflibercept) intravitreal injection 40 mg/mL for the treatment of preterm infants with retinopathy of prematurity (ROP).

  • Thermo Fisher Scientific gets FDA nod for Oncomine Dx Target Test

    The U.S. Food and Drug Administration (FDA) has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid cancer and RET-mutation positive advanced or metastatic medullary thyroid cancer (MTC) who may be eligible for treatment with Lilly’s Retevmo (selpercatinib).

  • Torrent Pharma to acquire Curatio Healthcare

    Torrent Pharmaceuticals Limited (Torrent Pharma) has entered into definitive agreements to acquire 100% of Curatio Healthcare (I) Private Limited (Curatio) for Rs. 2,000 crores. The consideration includes Rs. 115 crores (on the date of signing) of cash and cash equivalents in the acquired business indicating an Enterprise Value of Rs. 1,885 crores.

  • Pfizer and BioNTech seeks approval for Omicron Vaccine Booster in children

    Pfizer Inc and BioNTech SE announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.

  • Natco Pharma has launched Chlorantraniliprole in India

    Natco Pharma has launched Chlorantraniliprole (CTPR) 18.5% SC under the Brand Name of NATGEN in the Indian Market.

    NATCO estimates the current market size of CTPR containing products in India to be over INR 2000 crores.

  • EMA Recommends Granting a Conditional Marketing Authorisation for Loncastuximab Tesirine

    The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product loncastuximab tesirine (Zynlonta), intended for the treatment of adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma.

    The applicant for this medicinal product is ADC Therapeutics (NL) B.V.

  • Shilpa medicare bags CDSCO approval for Tranexamic Acid Spray

    Shilpa medicare gets CDSCO approval for Tranexamic Acid Spray, Hemostatic Spray. The product is protected by granted patents in India till 2037 and in US, Australia, Russia and South Africa till 2038. Shilpa is continuously pursuing patent prosecution in other countries and for further protection.

  • Eminence Business Medias organized grand event on 4th Annual Pharma Manufacturing & Automation Convention, 2022

    This two-day event was held on September 15th and 16th.It was a uniquely planned event, where the focus was on understanding how organisations can build an apt strategy for achieving manufacturing excellence and using digital and automation as tools for modernising.
    The conference ensured continuous engagement of the audience & speakers through various discussions in the form of Case-Study solving, Panel Discussion and group discussions to understand and create a viable Business Strategy for exponential growth.

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