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Results For "USFDA"

1126 News Found

Lupin receives tentative approval for Brexpiprazole tablets
Drug Approval | October 06, 2021

Lupin receives tentative approval for Brexpiprazole tablets

This product will be manufactured at Lupin’s Pithampur facility In India


Veeda Clinical Research files DRHP for Rs 831 crore IPO
News | October 01, 2021

Veeda Clinical Research files DRHP for Rs 831 crore IPO

The issue will consist of the issuance of fresh equity shares worth up to Rs 331.60 crore and an offer for sale (OFS) of Rs 500 crore by promoters and existing shareholders


Zydus Cadila receives final nod for anti-depressant
Drug Approval | September 18, 2021

Zydus Cadila receives final nod for anti-depressant

The medicine helps restore the balance of certain natural substances (serotonin) in the brain


Accutest enables NMPA approval for Qilu’s Abiraterone
Drug Approval | September 06, 2021

Accutest enables NMPA approval for Qilu’s Abiraterone

The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India


Alembic JV Aleor receives US FDA final approval for skin disorder gel
Drug Approval | September 06, 2021

Alembic JV Aleor receives US FDA final approval for skin disorder gel

Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea


Ami Organics bets on strategic acquisitions as its IPO opens on Sept 1
News | September 01, 2021

Ami Organics bets on strategic acquisitions as its IPO opens on Sept 1

The company aims to continue its expansion via organic and inorganic routes to increase production capacity and product portfolio


Dr. Reddy's announce launch two drugs in the US market
News | August 31, 2021

Dr. Reddy's announce launch two drugs in the US market

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP are available in one strength of 5 mg/2.5 mg capsules in bottle count sizes of 100


Indoco’s AnaCipher receives UK-MHRA accreditation
Drug Approval | August 27, 2021

Indoco’s AnaCipher receives UK-MHRA accreditation

The clinical research organisation located in Hyderabad is a USFDA inspected facility


Marksans announces US FDA approval for Acetaminophen Extended- Release tablets
News | August 27, 2021

Marksans announces US FDA approval for Acetaminophen Extended- Release tablets

The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India


Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection
Drug Approval | August 27, 2021

Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection

The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials