Morepen Laboratories files first ANDA application in the US for sitagliptin tablets
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Morepen Laboratories files first ANDA application in the US for sitagliptin tablets

Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for sitagliptin USP tablets in three dosages: 25 mg, 50 mg, and 100 mg. This move marks the company's entry into the U.S. market for finished dosage form development and regulatory reporting.

This submission expands Morepen's existing capabilities in Active Pharmaceutical Ingredients (API) and Contract Development and Manufacturing Organization (CDMO), including formulation development, bioequivalence, analytical validation, stability studies, and manufacturing processes for regulatory batches.

Sitagliptin is a DPP-4 inhibitor used to treat type 2 diabetes. The innovative product, Januvia, recorded global sales of $1.6 billion in 2025, according to Merck's 2025 annual report.

Management Statements

Sanjay Suri, Managing Director of Morepen Laboratories, noted that the first ANDA submission integrates the scientific, manufacturing, and regulatory expertise required to advance an API through finished dosage form development for submission in the US. Suri also added that alongside the planned Innovation Center and investments in advanced chemistry and technology, this strengthens the company's ability to undertake specialized CDMO assignments and build long-term development partnerships.

Morepen forecasts that from the date of submission to approval and commencement of commercial supply will take between 24 and 36 months, contingent upon FDA review, appropriate site inspections, and compliance with patent and exclusivity requirements.

The relevant patent for sitagliptin phosphate salt in the US expires in November 2026, and parenteral exclusivity is extended until May 2027. Morepen reported that some manufacturers have separate agreements allowing them to enter the market earlier.

The company emphasized that this program enhances its potential in executing specialized CDMO assignments, covering API development, finished dosage form formulation, and regulatory filings. It plans to develop this competency through customer development programs, technology transfer, joint development, and licensing opportunities.

ANDA number 221758 was filed on September 25, 2026. Morepen clarified that this filing alone does not signify acceptance by the FDA for substantive review, product approval, or authorization for commercial supply in the US.

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Construction of a new 'smart' city has begun in Khiva with the participation of a Pakistani company
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podrobno.uz

Construction of a new 'smart' city has begun in Khiva with the participation of a Pakistani company

The implementation of a large-scale investment project involving a Pakistani company has started in the city of Khiva. A modern settlement is planned for construction on a specially designated and expanding area of the city, which will include residential complexes, new social infrastructure, and modern transport facilities.

The practical phase of creating the 'smart' city in Khiva began thanks to the Pakistani construction and infrastructure firm Habib Rafiq Engineering. The concept of this project was discussed over several years with the assistance of the Embassy of Uzbekistan in Pakistan and representatives of the Khorezm Region Hokimiyat.

Representatives of the company repeatedly visited the region to study the proposed sites for construction. After inspecting the sites, the parties signed a memorandum of cooperation, followed by a memorandum of understanding between the Khorezm Region Hokimiyat and the company.

This project involves expanding the boundaries of Khiva and forming an entirely new urban quarter. The development of this area will be carried out using current methods in urban planning and ensuring the urban environment.

Construction work will proceed in stages. Within the new district, the construction of residential buildings, as well as social and commercial infrastructure facilities, road paving, engineering and utility networks, and other elements ensuring the convenience of residents' living will be planned.

Habib Rafiq Engineering intends to apply its accumulated experience gained during the construction of significant urban and infrastructure objects in Pakistan. It is worth noting that the first railway connecting the airport with the city was previously built in Khorezm.

Minister Goyal announces UAE's intention to invest another $25 billion in India
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business-standard.com

Minister Goyal announces UAE's intention to invest another $25 billion in India

India's Minister of Commerce and Industry, Piyush Goyal, stated that the United Arab Emirates (UAE) plans to inject an additional $25 billion into India in the near future. Furthermore, both countries aim to deepen cooperation in the fields of energy, ports, shipping, and logistics, with the UAE targeting a total investment sum of $100 billion in India.

Speaking after the fourteenth meeting of the India-UAE High-Level Joint Target Group on Investments on Monday, Goyal noted that the UAE is exploring investment opportunities in ports, shipbuilding, space, logistics, Indian startups, and the Indian stock market. The parties also identified six areas for cooperation in maritime transport and will establish a working group between the two nations.

These six areas include vessel ownership, development of modern ports, ship manufacturing, ship repair and maintenance, scrapping of vessels, and container fabrication, Goyal added.

Regarding the additional investments, Goyal emphasized: 'They have also expressed the intention to invest another $25 billion in the near term, with the ultimate goal of increasing investments from the UAE to $100 billion in the coming years.'

He mentioned that some of these new investments are already being made, citing investments of about $3 billion in RBL Bank and approximately $1 billion in Sammaan Capital.

Goyal also discussed the rise in local currency settlements between India and the UAE, noting that this figure has reached 'double-digit' levels. He explained that traders and travelers are gradually realizing the benefits of this approach, allowing transactions exclusively in rupees and dirhams, with the option to convert to US dollars or international currency after 3–6 months.

Additionally, India and the UAE are studying closer interaction in the field of energy security, including strategic oil reserves, LNG supplies, and subsea pipelines. Goyal noted that amid the current geopolitical situation and global uncertainty, the UAE stands as a reliable partner with whom work is underway to expand strategic oil reserves in India.

The minister also commented on port infrastructure, stating that India's port capacity has doubled over the last decade, and the country will need to double it again in the next decade as its economy grows. The UAE will play an important role as a trusted investor in the development or expansion of existing ports.

Potential areas for cooperation between India and the UAE were named as the Vadhavan ports in Maharashtra, ports to be established on the eastern coast of Odisha and Andhra Pradesh, and ports being developed along the western corridor between Karnataka and Kerala.

The minister also reported that India and the UAE have agreed to establish a more structured and official working group on issues such as civil aviation cooperation. Dialogue between the Indian Ministry of Civil Aviation and its counterparts from the UAE is already underway.

The last meeting also covered cooperation in space technology, food security, agri-innovations, logistics, artificial intelligence (AI), and fintech.

These developments occur against the backdrop of strengthening economic ties between India and the UAE. Bilateral trade has reached $100 billion, and the goal to double it to $200 billion by 2032 was previously approved by Prime Minister Narendra Modi and UAE President Sheikh Mohammed bin Zayed Al Nahyan earlier this year.

Goyal co-chaired the meeting with Sheikh Hamad bin Zayed Al Nahyan, Managing Director of the Abu Dhabi Investment Agency (ADIA)—one of the world's largest sovereign wealth funds that invests on behalf of the government of Abu Dhabi. Goyal reminded that the Comprehensive Economic Partnership Agreement between India and the UAE (CEPA), which came into force in May 2022, has been in effect for four years.

According to Goyal, the UAE has already invested $25 billion in India and is the seventh-largest source of foreign direct investment (FDI) for the country. He added that the UAE's interest extends beyond traditional investment sectors.

Regarding geopolitical tensions, the minister noted that they affect trade, but trade between the UAE and India is returning to pre-war levels. He expressed confidence that within a few months, trade will not only recover to pre-war levels but exceed them.

Concerning India's overall export figures, Goyal reported that merchandise exports increased by 'more than 15 percent' in the first six months of the year as of September 21, clarifying that these are unofficial figures and final numbers have not yet been published. In the last fiscal year, India registered exports of goods and services worth $863 billion, and the government has set a target to increase this figure to $1 trillion in the current fiscal year.

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