Company profile for Novel Laboratories, Inc.

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About

Founded in December of 2006 by industry veteran, Dr. Veerappan Subramanian, Novel Laboratories, Inc. is a full-service pharmaceutical company that develops, manufactures, markets and distributes difficult to develop, technology-driven specialty generics for the US and European markets. With its core competencies in generics, Novel has also filed for multiple new products with the FDA and is anxiously awaiting approval. The Co...
Founded in December of 2006 by industry veteran, Dr. Veerappan Subramanian, Novel Laboratories, Inc. is a full-service pharmaceutical company that develops, manufactures, markets and distributes difficult to develop, technology-driven specialty generics for the US and European markets. With its core competencies in generics, Novel has also filed for multiple new products with the FDA and is anxiously awaiting approval. The Company grows the majority of its products in-house in addition to partnering with pharmaceuticals worldwide to synergize development, manufacturing, and marketing capabilities.

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CONTACT DETAILS

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Country
Country
U.S.A
Address
Address
400 Campus Drive, Somerset, NJ 08873 
Telephone
Telephone
(908) 603-6000
Linkedin
Linkedin
youtube
YouTube
Twitter
Twitter

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NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207347

FDA
07 Aug 2023

https://www.pharmacompass.com/pdf/news/fda-issue-form-483-to-novel-laboratories-inc-dba-lupin-somerset-1652849037.pdf

FDA
17 May 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-25-2021-1629867988.pdf

FDA
25 Aug 2021

https://www.fda.gov/media/145108/download

FDA
14 Jan 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-9-2019-1547012578.pdf

FDA
09 Jan 2019

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615704.pdf

FDA
28 Nov 2018

Inspections and registrations

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FDA

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01

FDA Audited

USA
IPPE
Not Confirmed
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FDA Audited

USA
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IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2024-05-17

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02

FDA Audited

USA
IPPE
Not Confirmed
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FDA Audited

USA
arrow
IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-01-13

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03

FDA Audited

USA
IPPE
Not Confirmed
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FDA Audited

USA
arrow
IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-03-30

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04

FDA Audited

USA
IPPE
Not Confirmed
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FDA Audited

USA
arrow
IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2020-11-05

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05

FDA Audited

USA
IPPE
Not Confirmed
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FDA Audited

USA
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IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-11-08

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06

FDA Audited

USA
IPPE
Not Confirmed
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FDA Audited

USA
arrow
IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-02-23

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07

FDA Audited

USA
IPPE
Not Confirmed
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FDA Audited

USA
arrow
IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-08-08

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08

FDA Audited

USA
IPPE
Not Confirmed
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FDA Audited

USA
arrow
IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-02-14

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09

FDA Audited

USA
IPPE
Not Confirmed
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FDA Audited

USA
arrow
IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-11-17

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10

FDA Audited

USA
IPPE
Not Confirmed
arrow

FDA Audited

USA
arrow
IPPE
Not Confirmed

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2015-01-22

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