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Peptide Process CMCPeptide Process CMC
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28-30 August, 2025
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01-03 September, 2025
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01 September, 2025
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/50-years-of-innovation-mikart-s-legacy-and-what-s-next-in-cdmo-excellence
VLOG #PharmaReel
[Sponsored by another company]DATA COMPILATION #PharmaFlow
[Sponsored by another company]https://www.pharmacompass.com/radio-compass-blog/fda-approvals-drop-24-in-h1-2025-gsk-s-uti-med-vertex-s-non-opioid-painkiller-lead-pack-of-first-in-class-meds
15 Jan 2025
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-15-2025-7287.pdf
21 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/moleac-announces-pt-ferron-par-pharmaceuticals-as-new-exclusive-partner-in-indonesia-302281877.html
17 Jul 2024
// FDA
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp
22 Apr 2024
// Joseph Keenan FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/endos-par-pharma-issues-recall-blood-pressure-med-due-possible-contamination
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-pharmaceutical-issues-voluntary-nationwide-recall-one-lot-treprostinil-injection-due-potential
12 Mar 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/par-pharmaceutical-issues-voluntary-nationwide-recall-of-one-lot-of-treprostinil-injection-due-to-potential-for-silicone-particulates-in-the-product-solution-302087106.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18075
Submission : 2005-02-06
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16245
Submission : 2002-11-15
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23269
Submission : 2009-11-12
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19448
Submission : 2006-05-18
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21106
Submission : 2007-11-03
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22924
Submission : 2009-07-06
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22209
Submission : 2008-11-17
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21386
Submission : 2008-02-29
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22782
Submission : 2009-05-15
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23381
Submission : 2009-12-17
Status : Active
Type : II
Details:
Ephedrine Sulfate Injection (“Ephedrine”) in a prefilled syringe is a widely used injectable vasopressor agent indicated for the treatment of clinically important hypotension occurring during surgery.
Lead Product(s): Ephedrine Sulfate,Inapplicable
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Recipient: Nevakar
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 28, 2022
Lead Product(s) : Ephedrine Sulfate,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Recipient : Nevakar
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ephedrine Sulfate Injection (“Ephedrine”) in a prefilled syringe is a widely used injectable vasopressor agent indicated for the treatment of clinically important hypotension occurring during surgery.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 28, 2022
Details:
The U.S. District Court for the District of Delaware issue a temporary restraining order and preliminary injunction preventing the launch of Eagle’s recently approved vasopressin product.
Lead Product(s): Arginine Vasopressin,Inapplicable
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vasopressin-Generic
Study Phase: Approved FDFProduct Type: Peptide
Recipient: Eagle Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 29, 2021
Lead Product(s) : Arginine Vasopressin,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Recipient : Eagle Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The U.S. District Court for the District of Delaware issue a temporary restraining order and preliminary injunction preventing the launch of Eagle’s recently approved vasopressin product.
Product Name : Vasopressin-Generic
Product Type : Peptide
Upfront Cash : Inapplicable
December 29, 2021
Details:
Company has begun shipping varenicline, a generic version of Pfizer's Chantix® (varenicline) 0.5 mg and 1 mg tablets. Varenicline is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment.
Lead Product(s): Varenicline Tartrate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Endo International
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 22, 2021
Lead Product(s) : Varenicline Tartrate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Endo International
Deal Size : Inapplicable
Deal Type : Inapplicable
Endo Launches First and Only Generic Version of Chantix® (varenicline) Tablets in the United Stat...
Details : Company has begun shipping varenicline, a generic version of Pfizer's Chantix® (varenicline) 0.5 mg and 1 mg tablets. Varenicline is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 22, 2021
Details:
Undisclosed
Lead Product(s): Pimecrolimus,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 29, 2017
Lead Product(s) : Pimecrolimus,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 29, 2017
Details:
Undisclosed
Lead Product(s): Ciprofloxacin,Dexamethasone
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Novum Pharmaceutical Research Services
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 26, 2013
Lead Product(s) : Ciprofloxacin,Dexamethasone
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Novum Pharmaceutical Research Services
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 26, 2013
Details:
Undisclosed
Lead Product(s): Ciprofloxacin,Dexamethasone
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Novum Pharmaceutical Research Services
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 29, 2013
Lead Product(s) : Ciprofloxacin,Dexamethasone
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Novum Pharmaceutical Research Services
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
July 29, 2013
Details:
Undisclosed
Lead Product(s): Diclofenac,Inapplicable
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Novum Pharmaceutical Research Services
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 21, 2011
Lead Product(s) : Diclofenac,Inapplicable
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Novum Pharmaceutical Research Services
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 21, 2011
Details:
Undisclosed
Lead Product(s): Lisinopril,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: PharmaKinetics Laboratories
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 27, 2011
Lead Product(s) : Lisinopril,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : PharmaKinetics Laboratories
Deal Size : Inapplicable
Deal Type : Inapplicable
A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 27, 2011
Details:
Undisclosed
Lead Product(s): Doxycycline,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Anapharm
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 27, 2011
Lead Product(s) : Doxycycline,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Anapharm
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 27, 2011
Details:
Undisclosed
Lead Product(s): Doxycycline,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Anapharm
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 27, 2011
Lead Product(s) : Doxycycline,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Anapharm
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 27, 2011
Inspections and registrations
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Par Pharmaceutical is a supplier offers 29 products (APIs, Excipients or Intermediates).
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