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Results For "manufacturing-facility"

631 News Found

Zydus receives final approval from the USFDA for Minocycline Hydrochloride ER Tablets
Drug Approval | June 20, 2023

Zydus receives final approval from the USFDA for Minocycline Hydrochloride ER Tablets

The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.


USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit
News | June 17, 2023

USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

The inspection closed with zero observations


Briefs: Natco Pharma and Panacea Biotec
Drug Approval | June 16, 2023

Briefs: Natco Pharma and Panacea Biotec

Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products


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