Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma

Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA

Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem

Alkem Medtech to acquire 100% stake of Bombay Ortho

Indoco’s clinical research organisation ‘AnaCipher’ completes USFDA inspection

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity

USFDA classifies Aurobindo Pharma Inc's warehouse as OAI

The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years

Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.

Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP

Briefs: Gandhar Oil Refinery India, FDC and Apitoria Pharma

FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets