Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII

The unit is an oral manufacturing facility at Jedcherla, Hyderabad

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets

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

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

Apitoria Pharma gets Form 483 with 10 observations from USFDA

The observations are of procedural in nature and will be responded to within the stipulated time

Aurobindo Pharma to acquire balance 49% stake in GLS Pharma

Aurobindo Pharma’s subsidiary acquires Ace Laboratories, UK

Ace Lab conducts 170 batches of testing per month and has capacity to do more than 250 batches per month

Eugia SEZ’s injectable facility gets EIR from USFDA

The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated

Briefs: Lupin and Aurobindo Pharma

Lupin updates on shipment of Mirabegron ER Tablets

CuraTeQ Biologics announces the successful Phase 1 clinical study outcome of their BP11 product

Briefs: Eugia Pharma Specialities and Eugia SEZ

Eugia Pharma Specialities restarts production at terminally sterilized product lines