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Results For "Malaysia"

60 News Found

Azelis signs distribution agreement with Evonik to expands pharmaceutical offering in Malaysia and Singapore
Supply Chain | March 13, 2025

Azelis signs distribution agreement with Evonik to expands pharmaceutical offering in Malaysia and Singapore

This expanded partnership helps Evonik to streamline its distribution model in Asia Pacific


USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Drug Approval | January 13, 2025

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance


Venus Remedies gets approval from Malaysian PIC/S GMP for pre-filled syringe facility
News | November 06, 2024

Venus Remedies gets approval from Malaysian PIC/S GMP for pre-filled syringe facility

The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities


USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
Drug Approval | September 30, 2024

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations


USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia
Drug Approval | July 24, 2023

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories


Biocon Biologics insulins facility in Malaysia receives EU GMP Certification
News | October 26, 2022

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.


Biocon Sdn. Bhd. enters Malaysia Book of Records
Biotech | August 08, 2022

Biocon Sdn. Bhd. enters Malaysia Book of Records

The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR


Malaysia awards three-year contract for Biocon Biologics’ Insugen
Biotech | April 26, 2022

Malaysia awards three-year contract for Biocon Biologics’ Insugen

Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics


U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans