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Results For "ANDA"

2218 News Found

Lupin receives EIR from USFDA for injectable facility in Nagpur
News | February 18, 2023

Lupin receives EIR from USFDA for injectable facility in Nagpur

The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022


AstraZeneca Pharma India receives no objection for Durvalumab
Drug Approval | February 17, 2023

AstraZeneca Pharma India receives no objection for Durvalumab

Durvalumab in combination with chemotherapy is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer


GUERISON enters Indian Ophthalmology market
News | February 17, 2023

GUERISON enters Indian Ophthalmology market

The company has launched its new range of 25 allopathy ophthalmic products including GUERIMOD, GUERIPRED, BIMATO MST etc. for curing various diseases related to eyes


Briefs: Piramal Pharma, Alembic Pharmaceuticals
News | February 17, 2023

Briefs: Piramal Pharma, Alembic Pharmaceuticals

USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA


Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension
Drug Approval | February 16, 2023

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)


Thermo Fisher Scientific launches real-time PCR kits for detection of infectious diseases in India
Medical Device | February 15, 2023

Thermo Fisher Scientific launches real-time PCR kits for detection of infectious diseases in India

The Applied Biosystems TaqPath PCR kits have been analytically- and clinically-validated for use in patient care


NATCO files generic Olaparib Tablets in USA
News | February 14, 2023

NATCO files generic Olaparib Tablets in USA

Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer


India committed to strengthen traditional medicine practice by bolstering evidence-based research: Sonowal
Policy | February 13, 2023

India committed to strengthen traditional medicine practice by bolstering evidence-based research: Sonowal

The Ministry of Ayush endeavour is to get entry level NABH certification for 12,500 Ayush Wellness Centers by the end of 2023


Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules
News | February 11, 2023

Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules

The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product


Lupin receives approval from USFDA for Glycopyrrolate Injection USP
News | February 10, 2023

Lupin receives approval from USFDA for Glycopyrrolate Injection USP

The approval for Glycopyrrolate clears the path for more internally manufactured injectable products