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Alkem gets two observations from USFDA for USA plant

Alkem Laboratories on Saturday said the US health regulator has issued two observations after inspection of its St Louis-based manufacturing facility. The US Food...

Dr Reddy’s gets 3 observations from USFDA for US-based API plant

Dr Reddy''s Laboratories on Wednesday said the US health regulator has issued a Form 483 with three observations after inspecting its manufacturing...

USFDA issues 9 observations to Aurobindo Pharma

Hyderabad: The US Food and Drug Administration (FDA) has issued a 'Form 483' with nine observations to a manufacturing facility in the...

Biocon gets EIR from USFDA for small molecules API

Biocon stated that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the post...

Alembic Pharma receives 4 observations from USFDA

New Delhi: Alembic Pharmaceuticals on Monday said that US health regulator has conducted an inspection at it Panelav facility in Gujarat and issued...

USFDA completes inspection of Cadila with zero observations

Cadila Healthcare Ltd announced that US Food and Drug Administration (FDA) issued Form 483 with zero observations to the company's Baddi unit.

Biocon receives 2 observations from USFDA

The United States Food and Drug Administration (USFDA) issued a Form 483 with two observations to Biocon’ Bengaluru API facility.

Shilpa Medicare gets 15 observations from USFDA

Shilpa Medicare has received 15 observations from US Food and Drug Administration (FDA) for the company's finished dosage formulation facility (sterile...

Alkem Labs gets two USFDA observations

Alkem Laboratories Ltd has received two observations from US Food and Drug Administration (FDA) for the company's facility in Baddi, Himachal Pradesh.

USFDA inspection of Lupin with no observation

New Delhi: Drug firm Lupin Pharmaceuticals said the US health regulator has completed inspection of its Aurangabad facility in Maharashtra without any observation.

USFDA inspection at Lupin with 2 observations

New Delhi: Drug firm Lupin on said the US health regulator has issued two observations after inspection of the company's Madhya Pradesh facility.

JB Chemicals passes USFDA inspection with one observation

NEW DELHI: JB Chemicals and Pharmaceuticals said its Gujarat unit has passed the US health regulator's periodical inspection with one minor procedural observation.

USFDA’s inspection of Divis Lab: zero observations

Divis’s Laboratories has received zero Form 483 observations from US Food and Drug Administration (FDA) for Andhra Pradesh facility.

USFDA’s inspection of Biocon with 5 observations

New Delhi: Biocon Ltd said the US health regulator conducted a pre-approval inspection and good manufacturing practice (GMP) examination of the API manufacturing facility and...

USFDA’s inspection of Strides zero observations

New Delhi: Drug firm Strides Pharma Science on Friday said the US health regulator has completed inspection of its Alathur facility in Tamil Nadu with zero...

USFDA inspects Alembic Pharma

USFDA inspects Alembic Pharma New Delhi: Drug firm Alembic Pharmaceuticals said the US health regulator has conducted an...

Lupin gets 5 observations from USFDA

Lupin gets 5 observations from USFDA Drug firm Lupin said it has received five observations from the US health regulator after inspection of...

Lupin gets 2 observations from USFDA

Lupin gets 2 observations from USFDA Drug firm Lupin on Saturday said it has received two observations from the US health...

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