Tag Archives: approval

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Nystatin and Triamcinolone Acetonide Ointment USP, (US RLD -Mycolog-II Ointment), 100,000 units/gram and 1 mg/gram. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. It is used to treat …

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Valganciclovir Tablets 450mg from the United States Food and Drug Administration (USFDA). The company’s Valganciclovir Tablets 450mg is AB-rated generic therapeutic equivalent version of Roche’s Valcyte. It is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated …

Tata Power Company has received approval for issuance in one or more tranches, of noncumulative, redeemable, taxable, listed, rated securities in the form of Non-Convertible Debentures (NCDs) upto an aggregate amount not exceeding Rs 5,500 crore on private placement basis to any persons, entities, bodies corporate, companies, banks, financial institutions …

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil), a generic version of Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil), of Hill Dermaceuticals, Inc. According to IQVIA sales data for the 12 month …

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Clobazam Tablets, (US RLD-ONFI Tablet), 10 mg and 20 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Clobazam is used in combination with other medications to treat …

Lupin has received approval for its Triamcinolone Acetonide Ointment USP, 0.1% from the United States Food and Drug Administration (FDA) to market a generic version of Mylan Pharmaceuticals, Inc.’s (Mylan) Triamcinolone Acetonide Ointment, 0.1%. Lupin’s Triamcinolone Acetonide Ointment USP, 0.1% is the generic version of Mylan’s Triamcinolone Acetonide Ointment, 0.1%. …

Sunshield Chemicals has received a communication from Maharashtra Pollution Control Board (MPCB) to restart the manufacturing activities subject to fulfilling Effluent treatment conditions. Sunshield Chemicals is engaged in the manufacture of Antioxidants and specialities for prime global customers.

AMJ Land Holdings has received an approval for scheme of amalgamation of Pudumjee Investment & Finance Company, a wholly owned subsidiary of AMJ Land Holdings, with the company. This is subject to all requisite approvals including sanction by the National Company Law Tribunal. The Board of Directors of the company …

Strides Pharma Science’s step‐down wholly owned subsidiary, Strides Pharma Global Pte, has received approval for Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg from the United States Food and Drug Administration (USFDA). Gabapentin Capsules is a generic version of Neurontin Capsules of Pfizer. The product received approval in …

Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Colchicine Tablets USP (US RLD – ColcyrsTM), 0.6 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to prevent or treat attacks of gout (also …

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Clobetasol Propionate Cream, (USRLD Temovate Cream), 0.05%. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Clobetasol Propionate is a topical (for the skin) steroid used to treat inflammation …

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), NESINA Tablets, 6.25 mg, 12.5 mg and …

OCL India has received an approval from its board for implementation of the scheme of Arrangement and Amalgamation of the company and Dalmia Cement East (DCEL) & other associates into Odisha Cement (ODCL). Post-merger, ODCL shall be renamed as OCL India. The Board of Directors of the company at its …

Dr. Reddy’s Laboratories has received an approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox (aspirin and extended-release dipyridamole) Capsules in the United States market from the US Food and Drug Administration (USFDA). The company is working towards launching the product. The Aggrenox brand and …

Lupin has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg …

Glenmark Pharmaceuticals’ subsidiary — Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Hydrocortisone Valerate Cream USP, 0.2%, a generic version of Westcort Cream, 0.2%, of Sun Pharmaceutical Industries Inc. According to IQVIA sales data for the 12-month period ending …

Reliance Capital’s wholly owned subsidiary — Reliance Health Insurance has received R3 approval from Insurance Regulatory and Development Authority (IRDAI) for its new health insurance business. The new company will commence operations by the December quarter of 2018. Reliance Capital, a part of the Reliance Group, is one of India’s …

“The commissioner for metro rail safety has given the mandatory approval for the start of passenger operations for Janakpuri West-Kalkaji Mandir, subject to the fulfillment of certain conditions and stipulations,” a Delhi Metro Rail Corporation official said. The Magenta Line section has 16 stations, including two inter-change stations – Hauz …