12th February, 2021
Alembic Pharmaceuticals announces its wholly-owned subsidiary, Alembic Global Holding SA receives USFDA Final Approval for Treprostinil Injection, 20 mg/20 ml (1 mg/ml), 50 mg/20 ml (2.5 mg/ml), 100 mg/20 ml (5 mg/ml), and 200 mg/20 ml (10 mg/ml), Multiple-Dose Vials.
Alembic’s maiden injectable ANDA approval. Indicates Karkhadi injectable facility (F-3) has green signal from the US FDA. The F-3 EIR announcement is a formality now.
Edit done on Feb 22, 2021 (07.11am)
Incorrect conclusion above. This ANDA approval is no green signal for F-3 Karkhadi facility. This is Corden Pharma S.p.A. manufacturing as per source here. No mention of Alembic Karkhadi plant in there. My apologies for reaching wrong conclusion. Thanks to Amit Rajan and Manprit for writing.
Reference: Post #713 by Manprit Aurora below.