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Results For "ANDA"

2098 News Found

Lupin launches Thiamine Hydrochloride Injection USP in the US
Drug Approval | June 19, 2023

Lupin launches Thiamine Hydrochloride Injection USP in the US

Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.


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


SMi discloses £6 million seed funding round, bolsters team with new C-suite hire
News | June 15, 2023

SMi discloses £6 million seed funding round, bolsters team with new C-suite hire

Investment enables development of revolutionary multi-omic platform using super-resolution imaging technology for earlier disease detection and accelerated discovery of therapeutics


Airnov to showcase HDPE bottle range at upcoming CPHI China
News | June 15, 2023

Airnov to showcase HDPE bottle range at upcoming CPHI China

The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications


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


Ampath expands its footprint in Andhra Pradesh
Healthcare | June 14, 2023

Ampath expands its footprint in Andhra Pradesh

Launched Pathology Laboratory in Vijayawada offering a wide range of best-in-class diagnostic services with over 2500+ tests


GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer
Drug Approval | June 12, 2023

GSK receives USFDA file acceptance for Jemperli plus chemotherapy for the treatment of endometrial cancer

Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities


Asence Pharma commences new plant at Ranoli, Vadodara
News | June 10, 2023

Asence Pharma commences new plant at Ranoli, Vadodara

The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement


Health Ministry organizes webinar on Non-Alcoholic Fatty Liver Diseases
News | June 09, 2023

Health Ministry organizes webinar on Non-Alcoholic Fatty Liver Diseases

Health Secretary highlights the need for capacity building programmes for Medical Officers to tackle Non Communicable Diseases at the primary level