Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Haloperidol Decanoate
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Caplin Steriles gets USFDA Approval for Haloperidol Decanoate Injection
Details : Haldol-Generic (haloperidol decanoate) is 5-HT2a/D2 receptor inhibitor small molecule. It is indicated for the treatment of patients with schizophrenia.
Product Name : Haldol-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 14, 2025
Lead Product(s) : Haloperidol Decanoate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Vitamin K1
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Caplin Steriles gets USFDA Approval for Phytonadione Injectable Emulsion
Details : Vitamin K1, also called phytonadione, is a cofactor of the enzyme γ-carboxylase, which activates precursors to coagulation factors II, VII, IX, and X, in patients with blood clotting disorders.
Product Name : Vitamin K1-Generic
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
April 24, 2025
Lead Product(s) : Vitamin K1
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Labetalol Hydrochloride
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Caplin Steriles Gets USFDA Nod for Labetalol Hydrochloride Injection
Details : U.S FDA has given Abbreviated New Drug Application labetalol hydrochloride injection USP, 100 mg/20 mL (5 mg/mL) and 200mg/40 mL (5 mg/mL) multiple-dose vials, a generic therapeutic equivalent version of Trandate injection, of Sebela Ireland Limited.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 09, 2021
Lead Product(s) : Labetalol Hydrochloride
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Prochlorperazine Edisylate
Therapeutic Area : Gastroenterology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Caplin Steriles Receives USFDA Approval for Prochlorperazine Edisylate Injection
Details : Abbreviated New Drug Application (ANDA) is granted for Prochlorperazine Edisylate Injection USP, 10 mg/2 mL (5 mg/mL) Vials presentations, a generic therapeutic equivalent version of (RLD), COMPAZINE Injection, of SmithKlineBeecham Corporation, USA.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 23, 2021
Lead Product(s) : Prochlorperazine Edisylate
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Milrinone
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Caplin Steriles Gets US FDA Approval for Generic Bloxiverz Injection
Details : Caplin Steriles has been granted final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) neostigmine methylsulfate injection USP, 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL).
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 22, 2021
Lead Product(s) : Milrinone
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Milrinone
Therapeutic Area : Cardiology/Vascular Diseases
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Caplin Steriles Receives Final USFDA Approval for Milrinone Lactate Injection
Details : Caplin Steriles has been granted final approval from the USFDA for its ANDA Milrinone Lactate Injection USP, 10 mg/10 mL, 20 mg/20 mL, 50 mg/50 mL, Single-dose vial presentation, a generic therapeutic equivalent version of, PRIMACOR Injection, 1 mg/mL, o...
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 19, 2021
Lead Product(s) : Milrinone
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable