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Results For "manufacturing-facility"

648 News Found

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets
Drug Approval | June 14, 2023

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States


Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany
Drug Approval | June 10, 2023

Indoco's Baddi facility receives EUGMP certification from Health Authority of Germany

The EU certification will support supplies of drug products registered in Europe, from this manufacturing site


Zydus receives final approval from USFDA for Esomeprazole Magnesium
Drug Approval | June 09, 2023

Zydus receives final approval from USFDA for Esomeprazole Magnesium

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)


Zydus receives final approval from the USFDA for Tadalafil Tablets USP
Drug Approval | June 08, 2023

Zydus receives final approval from the USFDA for Tadalafil Tablets USP

Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)


Briefs: Ipca Laboratories, Lupin and Zydus
News | June 05, 2023

Briefs: Ipca Laboratories, Lupin and Zydus

The company has extended its full co-operation and support to the officials of the Income Tax Department


Laurus Labs to increase stake in ImmunoACT to 33.86%
News | June 01, 2023

Laurus Labs to increase stake in ImmunoACT to 33.86%

This fresh infusion of capital will enable ImmunoACT to fast track the additional supply of the lead candidate HCAR-19


Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection
Drug Approval | May 22, 2023

Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection

Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States


Strides Puducherry facility receives EIR  from USFDA
Drug Approval | May 20, 2023

Strides Puducherry facility receives EIR from USFDA

The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.


Envision Scientific receives IGBC Gold Certification for India factory
News | May 17, 2023

Envision Scientific receives IGBC Gold Certification for India factory

Concept Medical’s manufacturing arm has reduced its carbon footprint via in-house efficiency improvement programmes & green infrastructure


Hikal announces USFDA audit with zero observations
Drug Approval | May 16, 2023

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites