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USFDA

Unichem gets tentative USFDA nod for drug to treat Diabetes

Unichem Laboratories has received tentative approval for ANDA of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United...
Medicine

Unichem Labs gets USFDA approval for Amitriptyline HCL Tablets

Unichem Laboratories has received ANDA approval for its Amitriptyline HCL Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg...
Medicine Tablet

Unichem gets USFDA nod for Guanfacine Tablets

Unichem Laboratories has received ANDA approval for its Guanfacine Tablets, USP 1 mg and 2 mg from the United States Food and...
Medicine

Unichem gets USFDA approval for Apremilast Tablets

Unichem Laboratories has received ANDA approval for its Apremilast Tablets, 10 mg, 20 mg and 30 mg from the United States Food...
USFDA

Unichem gets USFDA nod for Zonisamide Capsules

Unichem Laboratories has received ANDA approval for its Zonisamide Capsules, USP 25 mg, 50 mg and 100 mg from the United States...
USFDA

USFDA approves Unichem’s Atenolol and Chlorthalidone Tablets

Unichem Laboratories has received ANDA approval for its Atenolol and Chlorthalidone Tablets, USP 50 mg/25 mg and 100 mg/25 mg from the...
USFDA

Unichem gets USFDA nod for Tolterodine Tartrate tablets

Unichem Laboratories has received ANDA approval for its Tolterodine Tartrate Tablets, USP 1 mg and 2 mg from the United States Food...
Medicine

Unichem Labs gets USFDA nod for generic Lioresal tablets

Unichem Laboratories Limited has received ANDA approval for its baclofen tablets, USP, 10 mg and 20 mg from the United States Food...
Medicine

Unichem Labs gets USFDA nod for muscle spasm tablets

Drug firm Unichem Laboratories on Tuesday said it has received approval from the US health regulator to market its Cyclobenzaprine Hydrochloride tablets used for relief of muscle spasm in the...
Medicine

Unichem, Lupin recall hypertension medicines

Unichem Laboratories and Lupin are separately recalling certain batches of drugs from the US market due to quality issues.
Medicine

Unichem Labs gets USFDA nod to market anxiety disorder tablets

New Delhi: Drug firm Unichem Laboratories on Friday said it has received approval from the US health regulator to market its generic Buspirone Hydrochloride tablets used...
USFDA

Alembic gets USFDA nod for Clomipramine HCL Capsules

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for...

Covaxin receives GMP certificate from Authorities of Hungary

Covaxin has received a certificate of Good Manufacturing Practice (GMP) compliance from the Hungarian authorities, Bharat Biotech said in a statement.
Medicine

Alkem launches Ibuprofen, Famotidine tablets

Alkem Laboratories has launched Ibuprofen and Famotidine tablets, used to relieve the symptoms of rheumatoid arthritis and osteoarthritis, in the US market,...
USFDA

USFDA inspection ends with ‘Zero’ observations: Alkem

Drug firm Alkem Laboratories yesterday said the US health regulator has conducted an inspection of its Taloja facility in Maharashtra, and it...
Medicine Tablet

Bal Pharma launches Favipiravir tablets in India

Bal Pharma announced the launch of Favipiravir formulation in the Indian market, under the brand name BALflu. Favipiravir is...
Medicine Tablet

Black Fungus: MSN Labs launches Posaconazole to treat black fungus

MSN Laboratories has launched posaconazole in India under the brand name PosaOne as 100 mg delayed release tablets & 300 mg injections...
Medicine Tablet

Lupin launches generic Nitazoxanide tablets

Global pharma major, Lupin Limited announced the launch of the authorized generic version of Alinia (nitazoxanide) tablets, 500 mg of Romark Laboratories,...
USFDA

Dr Reddy’s gets 3 observations from USFDA for US-based API plant

Dr Reddy''s Laboratories on Wednesday said the US health regulator has issued a Form 483 with three observations after inspecting its manufacturing...
Medicine Tablets

Dr Reddy’s launch Lansoprazole DR orally disintegrating tablets

Dr Reddy’s Laboratories announced the launch of Lansoprazole DR orally disintegrating tablets, a therapeutic equivalent generic version of Prevacid SoluTab Delayed-Release Orally...
Medicine

Glenmark Pharma receives USFDA nod for Topiramate ER capsules

Glenmark Pharma has received final approval from the US health regulator for Topiramate extended-release capsules, used to treat certain types of seizures.
Medicine Tablets

Dr Reddy’s Labs launches generic Sabril tablets

Dr Reddy's Laboratories Ltd announced the launch of vigabatrin tablets USP, 500 mg, a therapeutic equivalent generic version of Sabril (vigabatrin) tablets,...

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High Court restrains publishing Ads in a dispute on Chyawanprash

The Calcutta High Court has issued an interim injunction restraining Shree Baidyanath Ayurved Bhawan Pvt Ltd from issuing certain print and video...

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