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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


Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations
Drug Approval | October 14, 2023

Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally


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


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)


Lupin launches patient support program ‘Humrahi‘  for diabetes management
Healthcare | October 04, 2023

Lupin launches patient support program ‘Humrahi‘ for diabetes management

India has the highest prevalence of diabetes globally, with an estimated 77 million people living with the condition and an expected 134 million cases by 2045


SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance
Startup | October 03, 2023

SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance

SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology


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


Berhyanda gets nod for acquisition of up to 76.1% stake in Suven Pharmaceuticals
News | September 29, 2023

Berhyanda gets nod for acquisition of up to 76.1% stake in Suven Pharmaceuticals

The aggregate foreign investment, including investment from other foreign investors may be up to 90.1% shareholding in the company


USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana
Drug Approval | September 29, 2023

USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana

The delegation's visit covered a wide range of topics