Alembic Pharma gets EIR from USFDA for Karakhadi office Kumar Jeetendra | October 13, 2021 Drug firm Alembic Pharmaceuticals on Monday said it has received establishment inspection report (EIR) from the US health regulator for its new injectable facility at Karakhadi in Gujarat. The company has, ”received EIR from US Food and Drug Administration (USFDA) for the inspection carried out by them at our new injectable facility at Karakhadi during …
Lincoln Pharmaceuticals Ltd receives approval from Australian Regulator, TGA Kumar Jeetendra | October 9, 2021 Ahmedabad, October 8, 2021: Lincoln Pharmaceuticals Limited, one of India’s leading healthcare companies has received approval from Australia’s medicines and medical devices regulator – Therapeutic Goods Administration (TGA). Company’s manufacturing facility in Khatraj, Gujarat received the GMP clearance from TGA for all three departments Tablet, Capsule and Cream & Ointment, which will cover a wide …
Lupin gets speculative gesture from USFDA to market generic Brexpiprazole tablets Kumar Jeetendra | October 8, 2021 Drug firm Lupin on Wednesday said it has received tentative nod from the US health regulator to market generic Brexpiprazole tablets, which are used with anti-depressant medicines for the treatment of major depressive disorder, in the American market. The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market …
Eli Lilly and Cipla enter into a strategic partnership in India to enhance access to Lilly’s key diabetes products Kumar Jeetendra | October 4, 2021 Mumbai, Oct 04 2021: Eli Lilly and Company (India) Pvt. Ltd. (hereinafter referred as “Lilly”), headquartered in Gurgaon, is a wholly owned subsidiary of Eli Lilly and Company, a global biopharmaceutical company headquartered in Indianapolis, USA, and Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) announced its strategic partnership in …
Glenmark receives USFDA approval to market generic anti-biotic cream Kumar Jeetendra | September 22, 2021 Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market Clindamycin Phosphate Foam, an antibiotic used for treating bacterial infections, in the American market. The Mumbai-based firm has received final approval from the US Food and Drug Administration (USFDA) to market Clindamycin Phosphate Foam (1 per cent) which is …
Dr Reddy’s gets DCGI gesture to lead stage 3 trial of Sputnik Light in India Kumar Jeetendra | September 15, 2021 Dr Reddy’s Laboratories was granted approval by the drugs regulator to conduct Phase III trials of single-dose COVID-19 vaccination Sputnik Light. According to Hindustan Times, the subject expert committee (SEC), of the Central Drugs Standard Control Organisation CDSO (CDSO), had recommended to the Drugs Controller General of India(DCGI) that approval be granted to conduct Bridging …
Aleor Dermaceuticals gets USFDA gesture for generic antibacterial gel Kumar Jeetendra | September 13, 2021 Drug firm Alembic Pharmaceuticals on Monday said its joint venture Aleor Dermaceuticals has received approval from the US health regulator for generic Metronidazole gel, used in the treatment of inflammatory lesions of rosacea. Aleor Dermaceuticals Ltd has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) …
Granules India And Jubilant Cadista Recall Products In US Market Kumar Jeetendra | September 13, 2021 Granules India and Jubilant Cadista, two generic drug manufacturers, are recalling several goods in the United States, the world’s largest market for medicines, for various reasons. According to the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), Granules India’s US-based unit is recalling over 1.14 crore Naproxen Sodium tablets, a non-steroidal …
Aurobindo Pharma gets USFDA gesture for malignancy treatment injection Kumar Jeetendra | August 27, 2021 New Delhi, Aug 27 (PTI) Drug firm Aurobindo Pharma on Friday said its arm Eugia Pharma Specialities has received approval from the US health regulator for Cyclophosphamide injection, used in the treatment of several types of cancer. The company”s subsidiary “Eugia Pharma Specialities Ltd has received a 505(b)(2) NDA approval from the US Food & …
Cipla and Kemwell Biopharma announce execution of a joint venture agreement for developing, manufacturing and commercialising biosimilars Kumar Jeetendra | August 25, 2021 Mumbai, India, August 25, 2021: Cipla Limited (BSE: 500087 | NSE: CIPLA EQ, hereafter referred to as “Cipla”), a leading global pharmaceutical company and Kemwell Biopharma Private Limited, a leading biopharmaceutical Contract Development and Manufacturing Organisation (CDMO), announced execution of a joint venture agreement to develop, manufacture and commercialise biosimilars for global markets. For this …
Pfizer,AstraZeneca COVID-19 vaccines less viable against Delta variation: Oxford-drove study Kumar Jeetendra | August 19, 2021 The COVID-19 vaccines by Pfizer and AstraZeneca are less effective against the Delta variant of coronavirus compared to the Alpha variant, according to a study led by researchers at the University of Oxford.The researchers, however, noted that with Delta, Pfizer-BioNTech vaccine and Oxford-AstraZeneca preventive, known as Covishield in India, still offer good protection against new …
Pfizer submits information for third dose endorsement in US Kumar Jeetendra | August 17, 2021 Pfizer and BioNTech on Monday submitted preliminary clinical data to US health authorities as part of their effort to seek authorization for a third dose of their Covid-19 vaccine for all Americans. Last week, the United States approved the booster shot of Pfizer-BioNTech and Moderna vaccines for people with weakened immune systems. Pfizer and BioNTech …
