News about Regulation

USFDA Conducts Pre-Market Inspection at Pashamylaram Facility of Gland Pharma

USFDA Conducts Pre-Market Inspection at Pashamylaram Facility of Gland Pharma

The Company is committed to address the observations and will submit its response to USFDA within the stipulated time.

Regulation | 28/08/2023 | By Manvi 745

Gland Pharma Receives EIR From USFDA For Dundigal Facility

Gland Pharma Receives EIR From USFDA For Dundigal Facility

Gland Pharma shares gained nearly 3 percent in trade after receiving EIR.

Regulation | 25/08/2023 | By Manvi 906

Torrent Pharmaceuticals Receives EIR from USFDA for Dahej Facility

Torrent Pharmaceuticals Receives EIR from USFDA for Dahej Facility

The Dahej facility was placed under OAI by the USFDA based on the March 2019 Inspection outcome.

Regulation | 25/08/2023 | By Manvi 1752

Glenmark Pharma settles drug pricing case with US Department of Justice

Glenmark Pharma settles drug pricing case with US Department of Justice

Glenmark Pharma settles drug pricing case with US Department of Justice

Regulation | 24/08/2023 | By Sudeep Soparkar 789

Sun Pharma, Alembic recall drugs in US market

Sun Pharma, Alembic recall drugs in US market

Sun Pharma, Alembic recall drugs in US market

Regulation | 22/08/2023 | By Sudeep Soparkar 780

Flawless Pharma Pvt Ltd will spend USD 100 Million in Hong Kong and China Assets & Patents buyout

Flawless Pharma Pvt Ltd will spend USD 100 Million in Hong Kong and China Assets & Patents buyout

Flawless Pharma Pvt Ltd will spend USD 100 Million in Hong Kong and China Assets & Patents buyout

Regulation | 03/08/2023 | By Sudeep Soparkar 1156

Lupin Announces Resolution of US FDA Warning Letter for its Goa and Pithampur Facilities

Lupin Announces Resolution of US FDA Warning Letter for its Goa and Pithampur Facilities

This is after the satisfactory evaluation of the corrective actions taken by the company in response to the Warning Letter that was issued on November 6, 2017.

Regulation | 28/07/2023 | By Manvi 971

Income Tax Survey at Ipca Laboratories Ltd's plants

Income Tax Survey at Ipca Laboratories Ltd's plants

The Income Tax Department has carried out survey proceedings at the Company's offices in Mumbai and at Sikkim manufacturing plants between 30th May, 2023 to 3rd June, 2023.

Regulation | 06/06/2023 | By Sudeep Soparkar 664

US FDA Conducts GMP Inspection at Piramal Pharma's Digwal Facility

US FDA Conducts GMP Inspection at Piramal Pharma's Digwal Facility

The inspection that was held from March 27 to 31 was completed successfully with Zero Form-483 observations.

Regulation | 05/04/2023 | By Manvi 1635

Govt Cancels License of 18 Pharma Companies

Govt Cancels License of 18 Pharma Companies

As many as 76 pharma companies were inspected across 20 states/ UTs by a joint team of the state and central drug regulators.

Regulation | 05/04/2023 | By Manvi 672

 
 

 

 

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