Alembic Pharmaceuticals has announced that it has received the EIR from the USFDA

Alembic Pharmaceuticals has announced that it has received the Establishment Inspection Report (EIR) from the USFDA for its API-III manufacturing facility located in Karakhadi, Gujarat. The USFDA inspection was conducted from 17 March 2025 to 21 March 2025. Alembic had so far active 141 DMFs. There is a high likelihood that approximately 41 DMFs listed below could have been manufactured at the Karakhadi site.


API business could account for about 20% of Alembic's overall business, and therefore, the Karakhadi site would make a significant contribution to Alembic’s presence in the United States.


Comments

Post a Comment

Popular posts from this blog

Gland Pharma is expected to secure 180-day exclusivity for Angiotensin II Acetate.

Image
This week, Gland Pharma received approval from the US FDA for the Angiotensin II Acetate Injection 2.5 mg/mL. Gland Pharma's Angiotensin II Acetate Injection is a generic version of La Jolla Pharma's Giapreza. Giapreza's sales are approximately $58 million in the U.S. market for the twelve months ending March 2025. Angiotensin II (ATII) is a naturally occurring peptide hormone that produces endocrine, autocrine, paracrine, and intracrine hormonal effects. It is a potent direct vasoconstrictor that narrows both arteries and veins, subsequently raising blood pressure. Its half-life in circulation is approximately 30 seconds; however, in tissue, it may extend to 15-30 minutes. ATII increases the secretion of ADH and ACTH and may enhance sympathetic effects through direct actions on postganglionic sympathetic fibres. Additionally, it acts on the adrenal cortex, prompting the release of aldosterone. Several patents are listed in OB by La Jolla Pharma’s Giapreza product.  Product...
Read more

Medical Reimbursement System in the US, J-Code, and the Potential Impact on 505(b)(2) Applications with Recent Changes

US Medical Reimbursment System The medical reimbursement system in the United States is very complex. I am not aware of any such system existing at the national level in India, so I cannot draw any parallels. In India, health insurance is primarily for hospitalisations, and, based on my information (which is mainly based on my health insurance), other reimbursements are generally not covered. However, I could be wrong. In the United States, there is HCPCS. Healthcare Common Procedure Coding System (HCPCS).  HCPCS is a standardised coding system used mainly for billing and processing health insurance claims, especially for Medicare and Medicaid.  The Centers for Medicare & Medicaid Services (CMS) maintains it. HCPCS is divided into two levels: Level I, which uses Current Procedural Terminology (CPT) codes, and Level II, which provides codes for products, supplies, and services not included in CPT.  You will notice that in the United States, almost everything is covered...
Read more