Alembic Pharma Gets Final USFDA Nod for Lamotrigine Extended-Release Tablets

Key Takeaways from Alembic Pharma’s Nod for Lamotrigine Extended-Release Tablets:

• Alembic Pharmaceuticals has received final approval from the USFDA for its Lamotrigine Extended-Release Tablets in dosages of 200 mg, 250 mg, and 300 mg.
• The approved product is therapeutically equivalent to GlaxoSmithKline's Lamictal XR Extended-Release Tablets.
• The Lamotrigine tablets are indicated for additional therapy for primary generalised tonic-clonic seizures and partial-onset seizures in patients aged 13 and older, and for conversion to monotherapy for those already on a single antiepileptic drug.
• The estimated market size for these tablets is around USD 163 million for the twelve months ending June 2024, and Alembic now holds a total of 216 ANDA approvals from the USFDA.

This approval is for the company's Abbreviated New Drug Application (ANDA), which is therapeutically equivalent to GlaxoSmithKline's Lamictal XR Extended-Release Tablets.

The Lamotrigine tablets are indicated for use as an additional therapy for primary generalised tonic-clonic seizures and partial-onset seizures in patients aged 13 and older. They are also approved for conversion to monotherapy in patients aged 13 and older who are already receiving a single antiepileptic drug.

The estimated market size for Lamotrigine Extended-Release Tablets is approximately USD 163 million for the twelve months ending June 2024, according to IQVIA. With this approval, Alembic now has a total of 216 ANDA approvals from the USFDA, including 188 final approvals and 28 tentative approvals.

About Alembic Pharmaceuticals Limited:

Alembic Pharmaceuticals Limited is a pharmaceutical company focused on research and development, and it has been a leader in healthcare since 1907. Based in India, Alembic is publicly listed and produces generic medicines for markets around the world. Its modern research and manufacturing facilities are approved by regulatory bodies in many developed countries, including the USFDA. Alembic is a key player in the branded generics sector in India, with its products recognized by both doctors and patients, supported by a marketing team of over 5,000 people.

Key Takeaways from the Announcement

• Hi-Tech Pipes recorded a sales volume of 123,027 MT in Q2 FY25.
• Growth was driven by heightened demand in infrastructure, water transportation, and renewable energy sectors.
• Government spending on critical infrastructure and private investments in solar energy contributed significantly to this achievement.

As per a stock exchange filing, the company recorded its highest-ever quarterly sales volume of 123,027 MT in Q2 FY25, marking a 22.50% year-on-year (YoY) growth. For the first half of FY25, Hi-Tech Pipes achieved a sales volume of 245,182 MT, reflecting an impressive 32.55% YoY increase.

This growth was fuelled by a rise in demand across sectors such as infrastructure, water transportation, and solar energy. Despite the challenges posed by the monsoon season, Hi-Tech Pipes capitalised on opportunities driven by government investments in infrastructure projects and private investment in renewable energy projects.

About Hi-Tech Pipes Limited

Hi-Tech Pipes Limited is an Indian company involved in the manufacturing and supply of electric resistance welding (ERW) steel pipes, cold-rolled strips, and engineering products. Its main products include black hollow sections and round pipes, galvanised and pre-galvanised pipes, and cold-rolled coils (CR). These products serve various industries such as infrastructure, construction, automobiles, energy, agriculture, defence, engineering, and telecom. The company specialises in the production of steel tubes and pipes, with product brands like JalShakti, Organic Pipes, FireFighter, Bahubali, Pre-Gal, Casewell, Shakti, Flatmax, Crashguard, Pillar, ColorStar, and Metal GC Sheet. Hi-Tech Pipes operates five manufacturing facilities across Uttar Pradesh, Gujarat, Andhra Pradesh, and Maharashtra, with a total installed capacity of about one million metric tonnes per year.

Key Takeaway from the Award Win

• Transformers and Rectifiers (India) Limited received an order worth ₹565 crore from Power Grid Corporation of India Limited.
• The contract involves manufacturing transformers and reactors. 
• The order is expected to be completed by the financial year 2025-2026.

As per a stock exchange filing, this contract involves the manufacturing and supply of transformers and reactors with capacities ranging from 80 MVAr to 500 MVA and voltage classes from 420 kV to 765 kV. These transformers and reactors will play a crucial role in India’s power infrastructure.

The order is expected to be executed by the financial year 2025-2026. The company has confirmed that the promoter group and related entities have no involvement in the awarding of this contract, ensuring that it does not fall under related party transactions.

This order strengthens TRIL’s position in the Indian power sector, showcasing its capabilities in delivering high-quality power equipment for national infrastructure projects.

About Transformers And Rectifiers (India) Limited 

Transformers and Rectifiers (India) Limited is an Indian company that produces a variety of transformers, including power, furnace, and rectifier transformers, serving both domestic and international markets. The company offers power transformers ranging from medium to ultra-high voltage (up to 1200 kV AC) and from small (5 MVA) to large capacities (500 MVA). Their power transformer range includes auto transformers, generator step-up transformers, small and medium power transformers, trackside traction transformers, and auxiliary transformers. For rectifier transformers, the company provides products like bushing current transformers and instrument transformers. In distribution transformers, their range covers 250 kVA to 4000 kVA, with voltage levels from 11 kV to 33 kV. Their furnace transformers include electric arc furnace transformers, submerged arc furnace transformers, and ladle refining furnace transformers.

About Power Grid Corporation of India Limited

Power Grid Corporation of India Limited is a company focused on power transmission, responsible for planning, implementing, operating, and maintaining the Inter-State Transmission System (ISTS), along with telecom and consultancy services. The company operates in three segments: Transmission Services, Consultancy Services, and Telecom Services. Transmission Services handles the transmission of large-scale power across Indian states through high voltage networks. Consultancy Services offers expertise in transmission, distribution, and telecom sectors, covering planning, design, engineering, load dispatch, procurement, operation, maintenance, financing, and project management. The company uses spare optical fibres from its transmission network for telecom services. Its Smart Grid technology allows real-time monitoring and control of the power system.

Key Takeaways from Carborundum Universal Incorporation:

• Carborundum Universal Limited incorporated a wholly owned subsidiary, CUMI USA Inc., in Delaware, USA, on October 2, 2024.
• The new subsidiary will serve as a Special Purpose Vehicle (SPV) for the acquisition of membership interest in Silicon Carbide Products Inc.
• CUMI USA Inc. has a paid-up capital of USD 7 million and an authorised capital of USD 10 million, but it has not yet started operations, so no turnover is reported.
• The acquisition will involve cash consideration, with an initial subscription of USD 7 million for 70,000 shares, and the new entity will become a related party to Carborundum Universal Limited.

CUMI USA Inc. has a paid-up capital of USD 7 million and an authorised capital of USD 10 million. As a newly incorporated entity, it has not yet commenced operations, so its turnover is not applicable at this stage.

The new subsidiary will serve as a Special Purpose Vehicle (SPV) for the acquisition, and the membership interests in Silicon Carbide Products Inc. will be held by CUMI USA Inc. 

The acquisition will involve cash consideration, with an initial subscription to the share capital amounting to USD 7 million, divided into 70,000 shares of USD 100 each. 

About Carborundum Universal Limited:

Carborundum Universal Limited (CUMI), established in 1954 as a tripartite joint venture, is a leading provider of materials science engineering solutions. As part of the 120-year-old Murugappa Group, CUMI is listed on both the NSE and BSE. The company operates as a Mines to Market company with integrated processes that include mining, power generation, fusion, manufacturing, marketing, and distribution. With a workforce of over 5,500 employees worldwide, CUMI focuses on collaboration and innovation to develop high-quality material solutions and services in areas such as abrasives, electro minerals, ceramics, refractories, and energy storage materials. Their products serve various industries, including engineering, fabrication, automotive, infrastructure, steel, glass, power generation and distribution, mining, and aerospace. CUMI has a broad global presence, exporting products to more than 50 countries across six continents.