Studds Accessories Ltd. Receives SEBI’s Approval For Issuing IPO
Studds Accessories Ltd which makes helmets and other two wheeler accessories has received the approval from SEBI in order to issue Initial Public Offering (IPO)....
Tag : Observations
Alembic Pharma’s Panvel plant receives zero observations
The US health regulator had conducted an inspection at Alembic Pharmaceuticals, Panvel plant and has not issued any observations. In a BSE filing the company...
USFDA isssues 13 observations to Alkem’s Daman plant
The US health regulator has issued 13 observations, to Alkem Laboratories Daman facility and 1 to US plant. The inspection was conducted by the regulator,...
USFDA issues 3 observations to Alembic Pharma for Gujarat plant
The US health regulator has issued 3 observations to Alembic Pharmaceuticals Ltd, after inspecting its formulation facility in Panelav, Gujarat. In a regulatory filing the...
USFDA issues observations to Cipla’s Goa unit
Cipla has received observations for its Goa unit, from the US health regulator. The USFDA conducted a product specific pre-approval inspection, at Goa plant in...
Aurobindo Pharma receives 9 observations from USFDA
Aurobindo Pharma has received 9 Form 483 observations from USFDA, for its Unit IV injectable facility. Unit IV is situated in Pashamailaram near Hyderabad, where it...
Laurus Labs gets zero observations from USFDA
Laurus Labs has received Form 483 with zero observations for Unit 2 (the formulations unit). The United States Food and Drug Administration (USFDA) has successfully...
Biocon receives 6 observations from USFDA
Biocon has received 6 observations from the US health regulator, after it had inspected its Malaysia manufacturing facility. The company in a regulatory filing stated,...
Shilpa Medicare receives 10 observations for Telangana facility
Shilpa Medicare has received Form no 483 observations, related to SEZ formulation facilities situated at Jadcherla, Telangana, from the United States Food & Drug Administration (USFDA)....
Dr Reddy’s gets 3 observations from USFDA for its UK facility
The US health regulator has made three observations to Dr Reddy’s Laboratories UK facility after inspecting it. In a regulatory filing, Dr Reddy’s said that...