USFDA cGMP inspection completed at Cipla’s manufacturing facility in Pithampur

Cipla has informed that the United States Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at its Pithampur manufacturing facility from 6th – 17th February, 2023. On conclusion of the inspection, the company has received 8 inspectional observations in Form 483. The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time.

Zydus receives tentative approval from USFDA for Gabapentin Tablets

Zydus Lifesciences Limited’s subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) for Gabapentin Tablets (Once-Daily), 300 mg and 600 mg (USRLD: Gralise Tablets). Gabapentin Tablets had annual sales of US $90 million in the United States (IQVIA MAT December 2022). Gabapentin Tablets are indicated for the management of Phospheric Neuralgia (PHN). The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya. 

Neuland Laboratories gets ESG score of 48

Neuland Laboratories Limited was awarded an ESG (Environmental, Social and Governance) score of 48 out of 100 by S&P Global. The company’s score placed it in the 92nd percentile among 343 companies considered as industry peers during 2021 and 2022. The average ESG score in the said category during the defined period was 21. Neuland is committed to integrating sustainability and ESG priorities across its operations.