Thu, Nov 30, 2023
Eugia Pharma Specialities has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Budesonide Inhalation Suspension, the Hyderabad-based drug firm said in a regulatory filing.
Tue, Aug 22, 2023
The stock came under pressure after reports said that Aurobindo Pharma, along with Alembic Pharmaceuticals, is recalling different products in the US market due to manufacturing lapses.
As per the US health regulator's latest Enforcement Report, the US-based subsidiary of Alembic Pharmaceuticals is recalling 82,400 bottles of Tobramycin Ophthalmic Solution in the American market.
Sun, Aug 06, 2023
The US health regulator also pointed out the company's failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.
Tue, Jul 25, 2023
The approval granted by the US Food & Drug Administration (USFDA) is to manufacture and market Plerixafor Injection of strengths 24 mg/1.2 mL (20 mg/mL), single-dose vial, Aurobindo Pharma said in a regulatory filing.
Fri, Mar 31, 2023
The US Food and Drug Administration (USFDA) inspected Lupin's Pithampur plant from March 21 to March 29, 2023, and ended the inspection by issuing a Form-483 with ten observations, the drugmaker said in a filing. Lupin shares have been a top loser in the pharma pack today.
Sun, Feb 12, 2023
Sun Pharma had produced the lot at its Halol-based manufacturing facility in Gujarat. The affected lot was later distributed in the market by its US-based unit.
Sun, Jan 15, 2023
In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products.
Mon, Dec 19, 2022
For the 12-month period ended October 2022, the Cardene capsules 20 mg and 30 mg achieved annual sales of approximately USD 10.9 million, the company said citing IQVIATM sales data.
Wed, Apr 13, 2022
On Tuesday, Alembic Pharma arm got US FDA final nod for Lidocaine & Prilocaine cream USP, which is used to cause numbness before medical procedures.
Wed, Dec 22, 2021
Drug firm Zydus Cadila on Wednesday said it has received approval from the US health regulator to market Pimavanserin tablets, used in the treatment of certain mental disorders, in the American market.
Sun, Dec 19, 2021
Drug major Cipla on Sunday said it has received approval from the US health regulator to market the Lanreotide injection, used for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors, in the American market
Wed, Nov 17, 2021
The approved abbreviated new drug application (ANDA) for Mupirocin cream is therapeutically equivalent to the reference listed drug product (RLD), Bactroban cream (2 per cent) of SmithKline Beecham (Cork) Ltd, Ireland, the company said.
Tue, Oct 19, 2021
Dr. Reddy's Laboratories Ltd. has announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide capsules, from the U.S. Food and Drug Administration (USFDA).
Sun, Sep 12, 2021
As per the latest Enforcement Report by US Food and Drug Administration (USFDA), the US-based unit of Granules India is recalling over 1.14 crore Naproxen Sodium tablets, a non-steroidal anti-inflammatory drug used to treat pain, menstrual cramps, inflammatory diseases such as rheumatoid arthritis, gout and fever
Tue, Aug 10, 2021
Hong Kong-based Aurabeat on Tuesday said it has launched its United States Food and Drug Administration (USFDA)-approved air purifier in India priced in the range of Rs 17,000 to Rs 74,000 for different models, used for SARS-COV-2 disinfection.
Sun, Jun 13, 2021
Drug firm Lupin on Sunday said it has received a warning letter from the US health regulator for its Somerset facility in the US. The United States Food and Drug Administration (USFDA) had inspected the company's Somerset, New Jersey, facility from September 10, 2020, to November 5, 2020, Lupin said in a regulatory filing
Mon, Mar 30, 2020
"The flagship facility in Bengaluru is the largest manufacturing facility for the company with capabilities to produce finished dosage formulation products across multiple dosage formats including tablet, capsules, ointments, creams and liquids," it added.
Fri, Feb 21, 2020
The Company received a communication that the inspection conducted by the US Food and Drug Administration (USFDA) at our aforesaid Unit IV, from November 4, 2019, to November 13, 2019, is still open and under review
Sat, Apr 06, 2019
Tofacitinib is used alone or with other medications to treat moderate to severe forms of rheumatoid arthritis, the company said in a BSE filing.
Sun, Mar 17, 2019
Drug major Lupin Saturday said it has been cautioned by the US health regulator that its Somerset (New Jersey) facility may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed.
Thu, Jan 03, 2019
The impurity N-Nitrosodiethylamine (NDEA) was detected in quantities above the acceptable limit in certain tablets containing valsartan, the FDA said.
Mon, Dec 31, 2018
The sector has been volatile throughout the year due to constant news flow in the markets. Some giants of the sector witnessed objections over their manufacturing plants and medicine pricing in the U.S. markets.
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