Caplin Steriles gets USFDA approval for Norepinephrine Bitartrate Injection

Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) Single-Dose Vial, a generic therapeutic equivalent version of (RLD), LEVOPHED injection of Hospira Inc.

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients with acute hypotensive states. According to IQVIATM (IMS Health), Norepinephrine Bitartrate Injection USP had US sales of approximately $40 million for the 12-month period ending June 2023.

Zydus receives EIR for the formulation manufacturing facility at SEZ 2, Ahmedabad

Zydus Lifesciences Ltd has received the EIR report from the USFDA for the inspection conducted at the formulation manufacturing facility named 'SEZ 2' located at Pharmez, Ahmedabad from 3 rd to 7th July, 2023. This was a Pre-Approval Inspection (PAI) and had concluded with NIL observations.

Completion of US FDA Inspection at Unit IV of APL Healthcare

The United States Food and Drug Administration (US FDA) inspected the Unit IV, a Formulation manufacturing facility, of APL Healthcare Limited, a wholly owned subsidiary of AUROBINDO PHARMA LIMITED, situated at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh, from September 13 to September 19, 2023.

At the end of the inspection, a 'Form 483' was issued with 1 observation which is procedural in nature. We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest.