USFDA gives nod to Glenmark for Abiraterone Acetate tablets USP 500 mg
Glenmark Pharma has received final approval by the US Food and Drug Administration (USFDA) for Abiraterone Acetate Tablets USP, 500 mg, the...
USFDA completes inspection of Aurobindo Pharma with no remaining deficiencies
The pre-approval inspection of Aurobindo Pharma was carried out from 8 February 2022 to 15 February 2022. On completion of the inspection,...
Regulatory framework for Nutraceutical industry
Kavita Sharma, International Regulatory and Supply Chain Manager, Nutrify Today, explains why nutraceuticals require a more consistent and severe regulatory framework worldwide
Lupin, Glenmark, Dr Reddys recall these BP drugs
New Delhi: Homegrown drug majors Lupin, Glenmark and Dr Reddy's Laboratories are recalling different products in the US, the world's largest market for...
Indian Drug manufacturers and Exporters get 6-month time to export drugs to Nigeria
In a big relief for Indian drug manufacturers and exporters engaged in unprofessional act in connivance with Nigerian importers, the National Agency...
Pharma Companies told to test drugs for cancer-causing impurities
Nagpur: Drug makers have been cautioned against having carcinogenic or cancer-causing nitrosamine impurities in their products beyond the permissible limit.
USFDA approves Oral Form for the treatment of Amyotrophic lateral sclerosis (ALS)
USFDA has approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS).
USFDA gives nod to Sun Pharma Mesalamine extended release capsules
Sun Pharmaceutical Industries on Thursday said it has received final approval from the US health regulator for Mesalamine extended release capsules, used...
USFDA gives approval to Alembic Pharma for Arformoterol Tartrate Inhalation Solution
Alembic Pharma today announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New...
USFDA gives nod to Alembic for this generic solution for Inhalation
Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated...
USFDA gives 10 observations to Sun Pharm
New Delhi: Sun Pharma said the US health regulator has issued a 'Form 483' with ten observations after inspecting its Halol-based manufacturing plant...
USFDA gives tentative nod to Glenmark for Calcipotriene and Betamethasone Dipropionate foam
Glenmark Pharma has been granted tentative approval by the US Food and Drug Administration (USFDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%,...
USFDA gives tentative approval for this Hypertension drug
Zydus Lifesciences said its subsidiary Zydus Worldwide DMCC has received tentative approval from the US health regulator to market its generic version of Selexipag tablets, used...
USFDA gives tentative nod to Zydus for Selexipag tablets
Zydus Lifesciences’s subsidiary Zydus Worldwide DMCC has received tentative approval from the US Food and Drug Administration (USFDA) to market Selexipag tablets...
USFDA gives approval to Lupin Pregabalin capsules
Lupin, an innovation-led transnational pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New...
USFDA gives final approval to Aleor Dermaceuticals for Docosanol cream
Alembic Pharma today announced that its wholly owned subsidiary, Aleor Dermaceuticals has received final approval from the US Food and Drug Administration...
Pharma Sector: “Act as if every day is an Audit”
Dr Paranjape, as a veteran in the pharma sector, what are the main challenges faced by pharma companies in India which...
USFDA gives nod to these companies for Bortezomib for injection
Zudus
Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to market Bortezomib...
USFDA grants approval for drug to treat spondylitis
The US Food and Drug Administration (USFDA) has granted approval for AbbVie’s Rinvoq (upadacitinib; 15 mg, once daily) to treat adults wsith active ankylosing...
DCGI extends timeline for Pharma Firms to regularize 294 FDCs
Download DCGI letter, link given below: The Drug Controller General of India (DCGI) vide his letter dated 28-04-2022, has extended time to...
Pfizer’s C-19 drug fails test for preventing infections
Pfizer Inc. slid in extended trading after its C-19 treatment failed a late-stage study testing it as a way to prevent infections.
USFDA approves this oral heart disease drug
Bristol Myers Squibb said on Thursday the U.S. Food and Drug Administration (USFDA) approved its oral heart disease drug Mavacamten, making it the first...
Aurobindo, Sun Pharma recall products due to these reasons
New Delhi: Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the...
Drug recall: Pfizer recalls some batches of Blood Pressure drug due to this reason
Pfizer said on Friday it was voluntarily recalling five batches of its Accupril blood pressure tablets after finding elevated levels of a potential cancer-causing agent...