Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 33

Results For "generic"

711 News Found

Indoco receives EIR for its Plant I manufacturing facility in Goa
Drug Approval | May 04, 2023

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.


Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment
Drug Approval | May 03, 2023

Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment

It will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment


Laurus Labs Q4 FY23 consolidated PAT drops to to Rs. 102.98 Cr
News | April 28, 2023

Laurus Labs Q4 FY23 consolidated PAT drops to to Rs. 102.98 Cr

Q4 results was challenging driven by steep fall in CDMO revenues and higher upfront cost of Capex projects and R&D projects


Aurisco expands Oligonucleotide capacity
News | April 24, 2023

Aurisco expands Oligonucleotide capacity

The New State-of-Art OligoPilot 2000 solid-phase synthesizer adds cGMP manufacturing capacity to support and accelerate clinical and commercial oligonucleotide programs.


Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug
Drug Approval | April 11, 2023

Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.


Lupin receives tentative approval from USFDA for Valbenazine capsules
Drug Approval | March 28, 2023

Lupin receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).


Quantumzyme receives patent for development of green catalyst in India
News | March 25, 2023

Quantumzyme receives patent for development of green catalyst in India

The patent was granted for creating a green catalyst for one of the world's most significant chemical reactions


Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets
Drug Approval | March 24, 2023

Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets

Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).


Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets
Drug Approval | March 22, 2023

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets

Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)


Granules Consumer Health concludes FDA audit with zero observations
Drug Approval | March 22, 2023

Granules Consumer Health concludes FDA audit with zero observations

The audit is a pre-approval inspection for three products filed from the facility