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22-25 February, 2026
Industry Trade Show
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23-25 February, 2026
Clinical Trial Supply ...Clinical Trial Supply Europe
Industry Trade Show
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24-25 February, 2026
Digital content

19 Jan 2026
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/alcami-acquires-rtp-facility-to-further-expand-biologic-capabilities-302663871.html

16 Dec 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/alcami-expands-drug-product-manufacturing-capacity-to-meet-growing-demand-302643577.html

21 Oct 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/alcami-to-expand-laboratory-services-footprint-at-durham-nc-facility-to-meet-growing-demand-in-biologics-302590195.html

11 Jul 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/alcami-announces-key-leadership-appointments-in-drug-product-manufacturing-302501483.html

12 Feb 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/alcami-appoints-tori-e-arens-as-president-drug-product-302374325.html

12 Feb 2025
// CONTRACTPHARMA
https://www.contractpharma.com/breaking-news/alcami-names-tori-e-arens-as-president-of-drug-product/
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19025
Submission : 2005-12-13
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22915
Submission : 2009-06-30
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-24
DMF Number : 22681
Submission : 2009-03-31
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18336
Submission : 2005-05-09
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19151
Submission : 2006-02-03
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16812
Submission : 2003-08-28
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19170
Submission : 2006-02-13
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16481
Submission : 2003-03-24
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16936
Submission : 2003-10-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19736
Submission : 2006-11-07
Status : Inactive
Type : II

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Registrant Name : Takeda Pharmaceutical Company Korea Co., Ltd.
Registration Date : 2009-06-17
Registration Number : 22-4-ND
Manufacturer Name : Sterling Wisconsin, LLC@[Micro...
Manufacturer Address : W130 N10497 Washington Drive, Germantown, WI 53022, USA@20 Pacific Drive, Quakertown,...

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Registrant Name : Amgen Korea Ltd.
Registration Date : 2016-08-18
Registration Number : Su36-1-ND
Manufacturer Name : Sterling Wisconsin, LLC
Manufacturer Address : W130 N10497 Washington Drive Germantown, WI 53022-4448, USA

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Details:
PharmaTher is evolving to become a leader in ketamine-based solutions for mental health, neurological and pain disorders, and partnering with Alcami as our exclusive manufacturer for the clinical and commercial supply of ketamine.
Lead Product(s): Ketamine Hydrochloride
Therapeutic Area: Neurology Brand Name: Ketarx
Study Phase: Phase I/ Phase IIProduct Type: Controlled Substance
Recipient: PharmaTher
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 19, 2021

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Lead Product(s) : Ketamine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase I/ Phase II
Recipient : PharmaTher
Deal Size : Undisclosed
Deal Type : Agreement
PharmaTher Engages Alcami for Clinical and Commercial Manufacturing of Novel Ketamine Products
Details : PharmaTher is evolving to become a leader in ketamine-based solutions for mental health, neurological and pain disorders, and partnering with Alcami as our exclusive manufacturer for the clinical and commercial supply of ketamine.
Product Name : Ketarx
Product Type : Controlled Substance
Upfront Cash : Undisclosed
October 19, 2021

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Details:
Alcami is providing commercial manufacturing services for Trevena's newly approved OLINVYK. OLINVYK (oliceridine) injection is an opioid approved in adults for the management of acute pain severe enough to require an intravenous opioid analgesic.
Lead Product(s): Oliceridine
Therapeutic Area: Neurology Brand Name: Olinvyk
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Trevena
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 26, 2020

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Lead Product(s) : Oliceridine
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Trevena
Deal Size : Undisclosed
Deal Type : Agreement
Alcami Providing Commercial Manufacturing for Trevena’s Recently FDA Approved OLINVYK
Details : Alcami is providing commercial manufacturing services for Trevena's newly approved OLINVYK. OLINVYK (oliceridine) injection is an opioid approved in adults for the management of acute pain severe enough to require an intravenous opioid analgesic.
Product Name : Olinvyk
Product Type : Miscellaneous
Upfront Cash : Undisclosed
August 26, 2020

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Inspections and registrations
ABOUT THIS PAGE
Alcami is a supplier offers 12 products (APIs, Excipients or Intermediates).
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