 |
Corporate News
12-Jun-20
|
|
|
|
|
|
|
|
|
|
|
|
Caplin Steriles receives USFDA final approval for Phenylephrine Hydrochloride injection
|
|
|
|
|
|
|
|
Caplin Point Laboratories announced that its subsidiary, Caplin Steriles has been granted final approval from the United States Food and Drug
Administration (USFDA) for its Abbreviated New Drug Application (ANDA)
Phenylephrine Hydrochloride injection USP, 10 mg/mL Single-Dose Vial, 50 mg/5 mL (10mg/mL) Pharmacy Bulk Package, and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package, a generic therapeutic equivalent version of (RLD), VAZCULEP Injection, of Avadel Legacy Pharmaceuticals LLC.
According to IQVIATM (IMS Health), Phenylephrine
Hydrochloride injection USP had US sales data of approximately $45 million for the
12-month period ending Mar 2020. Caplin Steriles Limited, has developed and filed 17
ANDAs on its own and with partners, with 9 approvals so far.
Phenylephrine Hydrochloride injection is indicated for the treatment of clinically
important hypotension resulting primarily from vasodilation in the setting of
anesthesia.
|
|
|
|
Previous News |
Caplin Point Laboratories receives INVIMA approval for Softgel Capsules division at Puducherry
(
Corporate News
-
06-May-24
14:53
)
|
|
|
Caplin signs MoU with Govt. of Tamil Nadu
(
Corporate News
-
08-Jan-24
17:55
)
|
|
|
Caplin Point rises on USFDA nod for eye drops
(
Hot Pursuit
-
16-Apr-24
11:02
)
|
|
|
Caplin Point jumps after Q3 PAT rises 30% YoY to Rs 120 cr
(
Hot Pursuit
-
12-Feb-24
12:46
)
|
|
|
Caplin Point Laboratories announces board meeting date
(
Corporate News
-
10-May-24
11:22
)
|
|
|
Caplin Steriles receives USFDA approval for Ofloxacin Otic Solution
(
Corporate News
-
08-Jan-24
15:15
)
|
|
|
Caplin Steriles receives USFDA approval for Ofloxacin Ophthalmic Solution USP 0.3%
(
Corporate News
-
16-Apr-24
11:32
)
|
|
|
Caplin Point Laboratories fixes record date for final dividend
(
Market Beat
-
Reports
05-Sep-22
12:58
)
|
|
|
Caplin Point Laboratories consolidated net profit rises 30.06% in the December 2022 quarter
(
Results
-
Announcements
11-Feb-23
15:15
)
|
|
|
Caplin Point Laboratories allots 91,704 equity shares under ESOP
(
Corporate News
-
15-Dec-22
12:51
)
|
|
|
Board of Caplin Point Laboratories recommends interim dividend
(
Corporate News
-
13-May-22
09:58
)
|
|
|
|
|
|
Other Stories |
|
|
|
|
|
|
|
|
|
|
|
|
|