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| FDA Approval |
USFDA approval within 15 day's for Indian companies:
USFDA approval within 15 day's for Indian companies of this month is huge boost for indian pharmaceutical sector and most of the drugs are in pipeline for the USFDA approval.
Indian medicine are a high Quality and cheap in price as compare to other countries. Pharmaceutical sector is backbone of the india in recent days of COVID-19. Pharmaceutical sector is one of the sector where India is on surplus in export.
Let's see the USFDA approval in 15th days of this month:
1. Drug Product: Carbidopa and Levodopa
Organization: Zydus Cadila
The Ahmedabad based facility of Zydus cadila has got tentative USFDA approval for its Carbidopa and Levodopa ER Capsule.
This medicine is used in treatment of the "Parkinson's Disease" such as shakiness, stiffness, difficulty in moving or the condition like as Parkinson's.
Zydus Cadila group has total 295 approval till date and some are on waiting.
2. Drug Product: Empagliflozin Tablet
Organization: Lupin Pharma
Lupin pharma has received tentative approval from USFDA for its Empagliflozin Tablet. Empagliflozin is available in 2 different strength's.
This drug product is useful for the treatment of type 2 diabetes mellitus. It is a generic version of Jordiance Tablet.
3. Drug Product: Favipiravir Tablet (Favizen)
Organization: Zenara Pharma
Zenara pharam is a subsidiary company of the Biophore India Pharmaceutical. Zenara pharma has got approval for its drug product Favipiravir Tablet (Favizen) from Drug Controller General of India (DCGI) for its USFDA approved plant located at Hyderabad.
This medication is used in treatment option for the patients with mild and moderate symptoms of COVID-19.
4.Drug Product: Verdanafil Hydrochloride Tablet
Organization: Alembic Pharmaceutical
Alembic pharmaceutical has got approval for Abbreviated New Drug Application (ANDA) product Verdanafil Hydrochloride Tablet from USFDA for its 4 different strength.
This medication is used for treatment of Erectile Dysfunction.
Alembics pharmaceutical has total 127 ANDA approvals.
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5. Drug Product: Olanzapine Tablets USP
Organization: Indoco Remedies
Indoco Remedies has got approval for its ANDA product Olanzapine Tablet USP for it's 6 different strength.
This drug product is useful for treatment of Schizophrenia ans Bipolar Disorder. It is also useful in combination with other medication to treat the depression and mental condition.
6. Drug Product: Mycophenolate mofetil Tablet
Organization: Lupin Pharmaceutical
Lupin pharmaceutical has got approval for its product Mycophenolate Mofetil Tablet from USFDA in alliance with ConCord Biotech. It is generic version of Cellcept Tablet.
This drug product is used in the treatment of Prophylaxis of organ rejection in recipient of allogenic kidney, Heart, or Liver transplant in combination with immunosuppressants.
7. Drug Product: Tolterodine Tartrate Tablet
Organization: Unichem Lab
Goa based Unichem plant has got an approval for its ANDA product Toltetodine Tartrate Tablet from USFDA. This product is manufacturered in 2 different strength.
This medication is used in treatment of Overactive Bladder with symptom of urge urinary incontinence, urgency and frequency.
8. Drug Product: Tavaborole Topical Solution 5%
Organization: Aleor Dermaceutical
Aleor Dermaceutical is a joint venture of Alembic Pharmaceutical. Aleor Dermaceutical has got an tentative approval for its ANDA product Tavaborole Topical Solution.
Tavaborole Topical Solution is an antifungal solution. It is uses in the treatment of Onychomycosis of the Toenails.
9. Drug Product: Olapazib Film-Coated Tablet
Organization: Astrazeneca Pharma India
Astrazeneca pharma India has got approval from Drug Controller General Of India (DCGI) for its Olaparib Film-Coated Tablet. It is manufactured in 2 different strength.
This medication is uses in treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations.
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