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Results For "United-States-Food-and-Drug-Administration"

395 News Found

Lupin receives tentative approval from USFDA for Selexipag for injection
Drug Approval | November 04, 2023

Lupin receives tentative approval from USFDA for Selexipag for injection

This product will be manufactured at Lupin's Nagpur facility in India


NATCO Pharma announces successful completion of USFDA inspection
Drug Approval | November 02, 2023

NATCO Pharma announces successful completion of USFDA inspection

NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023


Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur
Drug Approval | October 23, 2023

Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur

The company is confident of addressing all the observations within the stipulated time


Lupin enters into BTA with Lupin Manufacturing Solutions
News | October 17, 2023

Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin enters into BTA with Lupin Manufacturing Solutions


Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution
Drug Approval | October 13, 2023

Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch


Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial
Drug Approval | October 09, 2023

Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide


Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Drug Approval | October 07, 2023

Lupin receives tentative approval from USFDA for Tolvaptan Tablets

Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)


Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals
News | October 03, 2023

Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals

Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company


Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
Drug Approval | September 30, 2023

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Briefs: Mankind Pharma and Sequent Scientific
News | September 26, 2023

Briefs: Mankind Pharma and Sequent Scientific

Mankind Pharma commences the commercial operations newly set-up plant in Udaipur