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Results For "observations"

259 News Found

Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories
Drug Approval | July 20, 2023

Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories

Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial


Briefs: Link Pharma Chem and Zydus
News | July 11, 2023

Briefs: Link Pharma Chem and Zydus

USFDA concludes inspection at Zydus' formulation manufacturing facility at SEZ 2, Ahmedabad


Granules India successfully completes Two US FDA Audits in a span of 2 weeks
Drug Approval | July 03, 2023

Granules India successfully completes Two US FDA Audits in a span of 2 weeks

The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.


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


Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
Drug Approval | June 16, 2023

Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam

The company will submit its comprehensive response on these observations to the US FDA


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


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


USFDA inspects contract manufacturing facility of Jubilant Pharmova at Montreal Canada
Drug Approval | June 01, 2023

USFDA inspects contract manufacturing facility of Jubilant Pharmova at Montreal Canada

The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.


Hikal posts FY23 PAT at Rs. 36 Cr
News | May 30, 2023

Hikal posts FY23 PAT at Rs. 36 Cr

Pharmaceutical sales was flat and stood at Rs. 309 crore as compared to Rs. 308 crore in Q4 FY22