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Results For "Latin-America"

131 News Found

Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21
News | December 01, 2022

Botanical Solution and Croda Pharma inks agreement to accelerate production for GMP QS-21

QS-21 in blockbuster Shingles vaccine, first vaccine approved for Malaria, promising RSV phase III candidate, and Covid-19 applications.


USFDA inspects Lupin's Mandideep Unit-1 facility
News | November 25, 2022

USFDA inspects Lupin's Mandideep Unit-1 facility

The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


Lupin receives tentative approval from USFDA for Doxycycline Capsules
Drug Approval | November 09, 2022

Lupin receives tentative approval from USFDA for Doxycycline Capsules

Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US


Balaxi Pharmaceuticals delivers strong growth in Q2 FY23
News | November 07, 2022

Balaxi Pharmaceuticals delivers strong growth in Q2 FY23

Revenue is up 23% whereas Profit After Tax expands 29% for the company


Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drug Approval | November 07, 2022

Lupin receives tentative approval from USFDA for Drospirenone Tablets

Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US


USFDA issues Form-483 for Lupin's Nagpur Unit-2
Drug Approval | October 31, 2022

USFDA issues Form-483 for Lupin's Nagpur Unit-2

The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US


Lupin launches Paliperidone Extended-Release Tablets in US
News | October 21, 2022

Lupin launches Paliperidone Extended-Release Tablets in US

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US


Matt Sause elevated as new CEO of Roche Diagnostics
People | October 04, 2022

Matt Sause elevated as new CEO of Roche Diagnostics

Sause will become CEO Roche Diagnostics and a member of the Corporate Executive Committee effective 1 January 2023.


Lupin receives US FDA approval for Mirabegron Extended-Release tablets
Drug Approval | September 30, 2022

Lupin receives US FDA approval for Mirabegron Extended-Release tablets

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US