It is interesting to note how Indian contract manufacturing organizations (CMOs) continue to lead the preferred generic active pharmaceutical ingredient (API) suppliers’ bandwagon in the tightly regulated markets, even as the companies’ dependence on the import of bulk drugs is going up by the day to meet local demand.

With a record number of drug master files (DMFs) filed with U.S. drug regulators, CMOs are strengthening their presence in the world’s largest pharma market. The case is not entirely different in the EU and other markets.

Analysts point out that India’s position as a low-cost supplier of a broad variety of APIs is unlikely to change in the immediate future due to the huge competitive advantage CMOs have over others.

Over the years, quite a few pure play API manufactures have graduated to the formulations business, leaving a gap between production and domestic demand. This is one of the key reasons for relying on imported APIs for making generics meant for domestic consumption.

Major API players in India remained committed to high level expansion activities, although the sector witnessed no significant outbound activity in terms of acquisitions in recent months.

Piramal Pharma Solutions (PPS) announced a $55 million investment to enhance its API manufacturing prowess across the Indian CDMO’s factories located in North America and India. New state-of-the-art, multi-purpose plants, with over 270kL of total capacity, will receive part of the fund. It will support the current pipeline of approximately 80 late-stage programs that PPS is assisting its partners with, at various global sites.

Piramal will also expand its potency footprint at the company’s plant in Riverview, MI and augment early development capabilities out of Ennore, IN through additions of GMP kilo labs and a pilot plant.

Its Morpeth, UK facility will be expanded with early development capabilities in both drug substance and drug product to better serve its European clients.

In addition, all the API sites will be bolstered with support functions such as analytical capabilities, R&D infrastructure, automation and IT systems, according to a company statement.

With these investments, PPS can now support the commercialization of its pipeline of over 80 programs that are in Phase II or beyond, while allowing additional capacity for future partnerships, according to Vivek Sharma, chief executive officer of Piramal.

PPS had added its third facility in North America by acquiring a 100% stake in Ash Stevens for $43 million last August.  

Another major API firm that has embarked on a large-scale expansion is Torrent Pharma. In November 2017, Torrent received environment clearance for setting up an API manufacturing unit in the western state of Gujarat with an approximately $46 million investment.

The new facility, with a production capacity of 21,415 tons per year, would cover 57,737 square meters in Kalol Taluk, the Ahmedabad-based firm said.

Torrent Pharma operates in cardiovascular, diabetology, pain management, gastro-intestinal and dermatology segments.

In other expansion news, reports said Hyderabad-based Natco Pharma is planning an additional investment of $15 million to expand capabilities in APIs and intermediates in a site in Tamil Nadu, South India. The expansion will see the firm’s production capacity go up to 66.32 tons per year from its existing 6.267 tons.

Looking at sustainable growth in third-party API business, the company expects to broaden its API portfolio in the coming years. Natco has over three dozen DMFs and more than ten products in its pipeline.

The firm has two API manufacturing facilities, one in Mekaguda village, Rangareddy district, Telangana and the other in Manali, Tamil Nadu. The Manali plant is manufacturing cytotoxic APIs and biotechnology-based products.

Natco’s manufacturing capacities are set to double in the next two years, the company said.

On the M&A front, Neuland Laboratories informed the Mumbai stock exchange that the company completed the acquisition of a facility from Arch Pharma Labs located near Hyderabad in December 2017. Arch Pharma Labs’ multi-product facility has a capacity to produce about 197 kL of APIs and intermediates.

The acquisition of the U.S. FDA compliant plant, which has capabilities for on-site development, analytical method development, quality control lab space and a pilot plant, is expected to provide operational flexibility to the CMO, which has been pure-play API producer for the last 30 years.

In February, SMS Lifesciences India of Hyderabad bagged Mahi Drugs, another API maker from Visakhapatnam for an undisclosed amount. SMS Lifesciences provides contract manufacturing services for APIs and intermediates.

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S Harachand
Contributing Editor

S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.