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Office of Pharmaceutical Manufacturing Assessment

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Office Profile

Comprehensive profile of Office of Pharmaceutical Manufacturing Assessment, including its role, location, and regulatory activities.

Records (13)
483 - Dr. Reddy’s Laboratories, LTD, Biologics

Biologics • September 12, 2025

483
483 - Alvotech HF

Drugs • July 4, 2025

483
EIR - Curia New Jersey, LLC

drugs • May 14, 2025

EIR
EIR - Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Drugs • January 6, 2025

EIR
EIR - Samsung Biologics Co., Ltd.

Biologics • July 30, 2024

EIR
MEMO - Novo Nordisk A/S

drugs • March 25, 2024

MEMO
483 - Samsung Biologics Co., Ltd.

September 1, 2023

483
EIR - ABC Pharmaceuticals

Biologics • July 15, 2022

EIR
483 - Chugai Pharma Manufacturing Co., Ltd., Ukima Plant

drugs • August 23, 2021

483
EIR - KBI Biopharma, Inc.

drugs • September 29, 2020

EIR
483 - Chugai Pharma Manufacturing Co. Ltd. (CPMC)

drugs • February 21, 2020

483
483 - Biocon Biologics Limited

May 1, 2018

483
483 - F2 Chemicals LTD

drugs • November 6, 2008

483

Showing 1 to 13 of 13 records

Related Offices (5)
Office of Compliance Intervention and Consultation
OCIC
Acting Division Director
Bureau of Environmental Health
Division of Nonprescription Drug Products
Division of Reproductive and Urologic Products
Office Information

Name

Office of Pharmaceutical Manufacturing Assessment

Abbreviation

OPMA

Country

USA

Postal Code

20993

State/Province

Maryland

City

Silver Spring

Address

10903 New Hampshire Avenue, White Oak Building 51

Office Website

Visit Website

ID: fe47b0bd-c1c6-4458-a8c9-15e4b073d3df

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