Alembic Pharmaceuticals announces its wholly owned subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Diclofenac Sodium Topical Gel, 3%. Kumar Jeetendra | August 1, 2022 Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 3%.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze Topical Gel, …
Aleor Dermaceuticals Limited receives USFDA Final Approval for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. Kumar Jeetendra | August 8, 2022 Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) …
Is Malnutrition and Muscle Loss Interlinked? Kumar Jeetendra | August 25, 2022 While many adults around the world are living longer, they are not necessarily living healthier. This results in them being unable to live their fuller lives. There are multiple factors that contribute to this lower than optimal health chart. One of the key and most obvious factors is nutrition or the lack of it. After …
Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets USP, 25 mg and 50 mg. Kumar Jeetendra | August 29, 2022 29th August 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Chlorthalidone Tablets USP, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, …
Cipla receives USFDA approval for generic version of Revlimid® (lenalidomide capsules) Kumar Jeetendra | September 7, 2022 Mumbai, India/ New Jersey, United States, September 7, 2022: Cipla Limited (BSE: 500087; NSE: CIPLA EQ) (“Cipla”) announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg from the United States Food and Drug Administration (US FDA). Cipla’s Lenalidomide …
Alembic Pharmaceuticals receives USFDA Final Approval for Paclitaxel Injection USP Kumar Jeetendra | October 27, 2022 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) Multiple-Dose Vials. This is the first product approval …
Alembic Pharmaceuticals announces its first injectable product approval from its General Sterile Facility – Final Approval for Glycopyrrolate Injection USP Kumar Jeetendra | November 1, 2022 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Injection USP, 0.2 mg/1 mL and 0.4 mg/2 mL (0.2 mg/mL) Single-dose Vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) Multiple-dose Vials. …
Everything You Need to Know About Pharmaceutical Lab Innovation Kumar Jeetendra | December 6, 2022 India’s pharmaceuticals industry is a major player in the global pharmaceuticals market. India is ranked third in the world for production volume and 14th for value. India is the world’s largest supplier of generic medicines, with a share of 20% in global supply. It is also the top vaccine manufacturer worldwide. India is also home …
USFDA approves Alembic Pharmaceuticals’ Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe Kumar Jeetendra | December 26, 2022 26th December, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-Dose Prefilled Syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), …
Alembic Pharmaceuticals’ Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, gain USFDA approval. Kumar Jeetendra | January 6, 2023 06th January 2023, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toviaz Extended-Release …
Alembic Pharmaceuticals gets USFDA tentative approval for 100 mg Acalabrutinib capsules. Kumar Jeetendra | January 20, 2023 Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Acalabrutinib Capsules, 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Calquence Capsules, 100 mg, of AstraZeneca UK Limited (AstraZeneca). Acalabrutinib Capsules are …
CIPLA launches CIPPOINT, a point-of-care gadget for non-communicable, infectious, and other disorders. Kumar Jeetendra | January 20, 2023 Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) today announced the launch of Cippoint, a point-of-care testing device. This state-of-the-art device offers a wide range of testing parameters including cardiac markers, diabetes, infectious diseases, fertility, thyroid function, inflammation, metabolic markers, and coagulation markers. The device is CE IVD approved – …
