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28 October-01 November, 2024
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28-31 October, 2024
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Webinars & Exhibitions
CPhI India 2024CPhI India 2024
Industry Trade Show
Not Confirmed
26-28 November, 2024
SupplySide West 2024SupplySide West 2024
Industry Trade Show
Not Confirmed
28 October-01 November, 2024
World Vaccine CongressWorld Vaccine Congress
Industry Trade Show
Not Confirmed
28-31 October, 2024
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/due-to-its-20-year-mastery-in-micronization-inke-has-emerged-a-cornerstone-in-treating-global-respiratory-diseases
VLOG #PharmaReel
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[Sponsored by another company]https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions
29 Oct 2024
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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021665
28 Aug 2024
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https://www.accesswire.com/909276/amphastar-pharmaceuticals-to-present-at-the-2024-wells-fargo-healthcare-conference
07 Aug 2024
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31 Jul 2024
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31034
Submission : 2016-12-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-03-14
DMF Number : 27837
Submission : 2014-03-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33714
Submission : 2019-08-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33036
Submission : 2018-08-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-02
Pay. Date : 2015-07-10
DMF Number : 29454
Submission : 2015-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33913
Submission : 2019-08-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-30
Pay. Date : 2012-12-12
DMF Number : 26070
Submission : 2012-06-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32700
Submission : 2018-05-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-16
Pay. Date : 2022-11-04
DMF Number : 31036
Submission : 2017-11-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-13
Pay. Date : 2015-11-16
DMF Number : 29876
Submission : 2015-11-09
Status : Active
Type : II
NDC Package Code : 52221-107
Start Marketing Date : 2014-07-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52221-105
Start Marketing Date : 2013-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER, FOR SUSPENSION (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52221-117
Start Marketing Date : 2015-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52221-114
Start Marketing Date : 2018-07-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (3kg/3kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52221-106
Start Marketing Date : 2013-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : INJECTION, POWDER, FOR SUSPENSION (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52221-116
Start Marketing Date : 2015-10-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52221-116
Start Marketing Date : 2015-10-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52221-123
Start Marketing Date : 2018-12-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52221-101
Start Marketing Date : 2010-04-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52221-104
Start Marketing Date : 2013-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER, FOR SUSPENSION (1kg/kg)
Marketing Category : BULK INGREDIENT
Details:
Amphastar intends to use the proceeds for the payment of milestone payments in connection with the acquisition of Baqsimi (glucagon) nasal powder, used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.
Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Brand Name: Baqsimi
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Undisclosed
Deal Size: $300.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement September 11, 2023
Lead Product(s) : Glucagon
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : $300.0 million
Deal Type : Private Placement
Details : Amphastar intends to use the proceeds for the payment of milestone payments in connection with the acquisition of Baqsimi (glucagon) nasal powder, used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.
Brand Name : Baqsimi
Molecule Type : Peptide
Upfront Cash : Undisclosed
September 11, 2023
Details:
Through the divestment, Amphastar will continue Lilly's mission to help more people benefit from Baqsimi (glucagon), the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes.
Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Brand Name: Baqsimi
Study Phase: ApprovedProduct Type: Peptide
Recipient: Eli Lilly
Deal Size: $1,075.0 million Upfront Cash: $625.0 million
Deal Type: Divestment June 30, 2023
Lead Product(s) : Glucagon
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Recipient : Eli Lilly
Deal Size : $1,075.0 million
Deal Type : Divestment
Amphastar Pharmaceuticals Completes Acquisition of BAQSIMI from Lilly
Details : Through the divestment, Amphastar will continue Lilly's mission to help more people benefit from Baqsimi (glucagon), the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes.
Brand Name : Baqsimi
Molecule Type : Peptide
Upfront Cash : $625.0 million
June 30, 2023
Details:
Through the divestment, Amphastar will continue Lilly's mission to help more people benefit from Baqsimi (glucagon), the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes.
Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Brand Name: Baqsimi
Study Phase: ApprovedProduct Type: Peptide
Recipient: Eli Lilly
Deal Size: $1,075.0 million Upfront Cash: $625.0 million
Deal Type: Divestment April 24, 2023
Lead Product(s) : Glucagon
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Recipient : Eli Lilly
Deal Size : $1,075.0 million
Deal Type : Divestment
Lilly to Divest BAQSIMI to Amphastar
Details : Through the divestment, Amphastar will continue Lilly's mission to help more people benefit from Baqsimi (glucagon), the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes.
Brand Name : Baqsimi
Molecule Type : Peptide
Upfront Cash : $625.0 million
April 24, 2023
Details:
Naloxone hydrochloride nasal spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Naloxone Hydrochloride-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2023
Lead Product(s) : Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amphastar Pharmaceuticals Receives FDA Approval for Naloxone Hydrochloride Nasal Spray 4mg
Details : Naloxone hydrochloride nasal spray, as an OTC emergency treatment for known or suspected opioid overdose. Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.
Brand Name : Naloxone Hydrochloride-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 08, 2023
Details:
Epinephrine injection USP, 1 mg/10mL (0.1 mg/mL) Single Dose Pre-Filled Syringe is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Lead Product(s): Epinephrine
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2022
Lead Product(s) : Epinephrine
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amphastar Pharmaceuticals Receives FDA Approval for Epinephrine Pre-Filled Syringes
Details : Epinephrine injection USP, 1 mg/10mL (0.1 mg/mL) Single Dose Pre-Filled Syringe is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 16, 2022
Details:
U.S. Food and Drug Administration approved the Company’s Abbreviated New Drug Application for Morphine Sulfate injection 1mg/mL in the 30mL Pump-Jet® Prefilled Syringe System.
Lead Product(s): Morphine Sulfate
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2021
Lead Product(s) : Morphine Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amphastar Pharmaceuticals Receives FDA Approval for Morphine Sulfate Injection
Details : U.S. Food and Drug Administration approved the Company’s Abbreviated New Drug Application for Morphine Sulfate injection 1mg/mL in the 30mL Pump-Jet® Prefilled Syringe System.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 03, 2021
Details:
U.S. Food and Drug Administration (“FDA”) has approved the Company’s Abbreviated New Drug Application (“ANDA”) for Dextrose injection 50% in the 50 mL Luer-Jet® Prefilled Syringe System.
Lead Product(s): Glucose
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2021
Lead Product(s) : Glucose
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amphastar Pharmaceuticals Receives FDA Approval for Dextrose Injection
Details : U.S. Food and Drug Administration (“FDA”) has approved the Company’s Abbreviated New Drug Application (“ANDA”) for Dextrose injection 50% in the 50 mL Luer-Jet® Prefilled Syringe System.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 29, 2021
Details:
U.S FDA has approved the Company’s Abbreviated New Drug Application (“ANDA”) for Atropine Sulfate injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System.
Lead Product(s): Atropine Sulfate
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Lead Product(s) : Atropine Sulfate
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amphastar Pharmaceuticals Receives FDA Approval for Atropine Sulfate Injection
Details : U.S FDA has approved the Company’s Abbreviated New Drug Application (“ANDA”) for Atropine Sulfate injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 06, 2020
Details:
The U.S. FDA has approved Abbreviated New Drug Application for Succinylcholine Chloride Injection USP, 200 mg/10 mL Multiple-Dose Vial. Amphastar’s drug product was determined by the FDA to be therapeutically equivalent to Succinylcholine Chloride Injection USP, 200 mg/10 mL.
Lead Product(s): Succinylcholine Chloride
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2020
Lead Product(s) : Succinylcholine Chloride
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The U.S. FDA has approved Abbreviated New Drug Application for Succinylcholine Chloride Injection USP, 200 mg/10 mL Multiple-Dose Vial. Amphastar’s drug product was determined by the FDA to be therapeutically equivalent to Succinylcholine Chloride Inje...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 09, 2020
Details:
Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial.
Lead Product(s): Epinephrine
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2020
Lead Product(s) : Epinephrine
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Epinephrine Injection, USP 30mg/30mL (1mg/mL) Multiple Dose Vial.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 27, 2020
Excipients
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Amphastar Pharmaceuticals is a supplier offers 21 products (APIs, Excipients or Intermediates).
Find a price of Arginine Vasopressin bulk with DMF offered by Amphastar Pharmaceuticals
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