MedPath

Wockhardt Seeks DCGI Approval for Fast-Acting Insulin Analog Aspart Injection

• Wockhardt has filed for approval of its fast-acting insulin analog, Aspart injection (ASPARAPIDTM), with the Drugs Controller General of India (DCGI) in India. • The Aspart insulin injection aims to help patients effectively manage their diabetes, offering a new treatment option in the growing Indian market. • The Indian market for Aspart insulin is currently estimated at over Rs 260 crore, with Wockhardt anticipating significant growth in the coming years. • Wockhardt is also developing additional insulin analogs and GLP-1 agonists to further enhance its diabetes care portfolio and provide more effective treatment solutions.

Wockhardt has announced the filing of its fast-acting insulin analog, Aspart injection (ASPARAPIDTM), with the Drugs Controller General of India (DCGI) for marketing approval. This move signifies Wockhardt's commitment to addressing the increasing prevalence of diabetes in India and globally. If approved, Aspart will be available in cartridges, vials, and prefilled disposable pens.

Market and Competition

The current market size for Aspart in India is estimated to be over Rs 260 crore, with only two other players currently offering similar products. Wockhardt anticipates substantial market growth in the coming years, driven by the increasing need for effective diabetes management solutions.

Wockhardt's Diabetes Portfolio Expansion

In addition to Aspart, Wockhardt is actively developing other insulin analogs and GLP-1 agonists. The company aims to create a comprehensive diabetes portfolio, providing patients with a wider range of advanced treatment options for managing their condition. This filing underscores Wockhardt's end-to-end capabilities in research & development, clinical studies, scale-up, and manufacturing of biosimilar products.

Wockhardt's Recent Regulatory Success

Recently, Wockhardt received a favorable recommendation from the Central Drugs Standard Control Organisation (CDSCO) for its antibiotic drug Miqnaf, used in treating community-acquired bacterial pneumonia (CABP) among adults.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Wockhardt's New Pneumonia Antibiotic Poised to Capture $500M Indian Market

Wockhardt has received CDSCO approval for a novel oral antibiotic targeting community-acquired bacterial pneumonia, with potential market size of ₹4,000-5,000 crore in India. The company expects to capture 65-70% market share within 4-5 years, while also pursuing international expansion and developing additional antibiotics in their pipeline.

Biocon and Zentiva Secure EU Approval for Liraglutide, a Generic Version of Victoza

Biocon and Zentiva have received EU approval for their generic Liraglutide formulation via a decentralized procedure, targeting Type-2 Diabetes and weight management.
The approval covers generic versions of Novo Nordisk's Victoza for Type-2 Diabetes and Saxenda for weight management, offering a cost-effective alternative.

Wockhardt's Antibacterial Drug Zaynich Shows Promise in Treating US Cancer Patient with Resistant Infections

Wockhardt's drug Zaynich (WCK 5222) successfully treated a US cancer patient with infections caused by highly resistant bacteria, facilitating a transplant.
The drug effectively neutralized resistance mechanisms like IMP, NDM, and OXA-48 in Pseudomonas aeruginosa and Klebsiella pneumoniae.

Medicus Pharma Raises $4 Million in IPO to Advance Skin Cancer Treatment

Medicus Pharma successfully closed a $4 million initial public offering (IPO) on Nasdaq, offering 970,000 units at $4.125 each.
The IPO proceeds will primarily fund a Phase 2 clinical trial of Medicus Pharma's doxorubicin microarray needle skinpatch for basal cell carcinoma.

Capricor Therapeutics Seeks Accelerated Approval for Duchenne Muscular Dystrophy Therapy

Capricor Therapeutics is pursuing accelerated FDA approval for its cell therapy to improve heart function in Duchenne muscular dystrophy patients.
The company's stock has surged following the announcement of its regulatory strategy, reflecting investor optimism.

Wockhardt's Nafithromycin Poised for India Launch After Positive Phase 3 Results

Wockhardt anticipates Indian regulatory approval for Nafithromycin 400mg, a novel pneumonia treatment, following successful Phase 3 clinical trials.
The drug, requiring only a three-day oral therapy, demonstrated a 97% success rate in clinical trials, addressing a significant unmet need in India.

Wockhardt's Novel Antibiotic Miqnaf Receives Favorable Recommendation for CABP Treatment in India

Wockhardt's Miqnaf (nafithromycin) received a favorable recommendation from the CDSCO's Subject Expert Committee for treating community-acquired bacterial pneumonia (CABP).
The recommendation is based on a comprehensive review of non-clinical and Phase 1-3 clinical studies conducted over 15 years.

Wockhardt's WCK 6777 Receives FDA Fast Track for Complicated UTIs and cIAIs After Phase I Success

Wockhardt's WCK 6777 (Ertapenem/Zidebactam) received FDA Fast Track designation for complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
A Phase I study of WCK 6777, conducted by the NIH, demonstrated a promising safety profile in 52 healthy volunteers with no serious adverse events.

Alembic Pharma Gains US FDA Approval for Generic Lamotrigine Extended-Release Tablets

Alembic Pharmaceuticals receives US FDA final approval for Lamotrigine Extended-Release Tablets USP (200 mg, 250 mg, and 300 mg).
The approved ANDA is therapeutically equivalent to GlaxoSmithKline's Lamictal XR, used to treat certain types of seizures.

4DMedical, TrivarX, and Artrya Advance with FDA Clearances and US Partnerships

4DMedical's CT LVAS receives FDA clearance, expanding functional lung imaging accessibility in the US after its Australian rollout.
TrivarX accelerates its Phase 2 study for Major Depressive Episode, aiming to validate its MEB-001 algorithm for screening and diagnosis.

Reference News

[1]
Wockhardt gains 4% on filing for DCGI's approval for its insulin injection | News on Markets
business-standard.com · Oct 16, 2024

Wockhardt shares rose 4.3% after filing for approval of its fast-acting insulin analog, Aspart injection, with India's D...

[2]
Wockhardt Approaches DCGI for Marketing Approval for Diabetes Drug - Outlook Business
outlookbusiness.com · Oct 16, 2024

Wockhardt's Aspart insulin injection highlights the company's comprehensive capabilities in biosimilars R&D, clinical st...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy