Video | Agriculture | Confidence | Economy | Energy | Employment | Finance | Media | Property | RBNZ | Science | SOEs | Tax | Technology | Telecoms | Tourism | Transport | Search

 

US approval for 'grass-fed' infant formula will take longer

Synlait Milk says US approval for 'grass-fed' infant formula will take longer


By Tina Morrison

Aug. 14 (BusinessDesk) - Synlait Milk, the NZX-listed milk processor, said regulatory approval for its 'grass-fed' infant formula in the US is taking longer than expected.

Rakaia-based Synlait is seeking approval from the US Food and Drug Administration for its 'grass-fed' infant formula to be sold in the world's largest economy ahead of a launch of the product with US partner Munchkin Inc. The companies said in a statement today that the FDA process, which had been expected to be completed this year, is now expected to take a further four to 12 months. The stringent process, known as a New Infant Formula Notification (NIFN), includes a range of trials, audits and documentation.

"The FDA’s NIFN process is thorough and requires time for comprehensive review," said Synlait managing director John Penno. "We remain confident Munchkin’s Grass Fed infant formula will be launched in the near future, however, the timing of the launch will be slightly later than we’ve initially signalled."

He said the new timing will not have a material impact on Synlait’s forecast volumes for the 2018 financial year. The company has previously said that significant manufactured volumes for the US market weren't expected until the 2018 financial year.

Synlait is expanding in the US, the world's second-largest infant formula market, to diversify its earnings away from China, the world's largest market. The company has worked for two years with Munchkin on the new 'grass-fed' formula which aims to meet demand for natural products in a market where much of the milk comes from intensive, factory-style dairy farms. The product is poised to become only the second imported infant formula brand with US FDA registration.

The company said today that the delay in the US launch has no impact on the strength of Munchkin’s Grass Fed infant formula, which continues to steadily gain increased distribution in Australia and New Zealand.

Synlait's shares last traded at $4.65 and have gained 25 percent in the past 12 months.

(BusinessDesk)

ends

© Scoop Media

 
 
 
 
 
Business Headlines | Sci-Tech Headlines

 

Fuel Leak: Refinery Prepares To Repair Damaged Pipeline

Refining NZ has confirmed that it is to start repairs on a section of its multi-product fuel pipeline which was shut down following a jet fuel leak last Thursday. More>>uption.htm">More>>

ALSO:

StatsNZ: Economy Grows 0.8% In June Quarter

“Strong export and domestic demand underpinned growth this quarter,” national accounts senior manager Gary Dunnet said. “Demand for exports has resulted in strong production growth in manufacturing and service industries.” More>>

ALSO:

Stats NZ: Annual Net Migration Remains High

Annual net migration was 72,100 in the August 2017 year... Migrant arrivals reached 132,200, a new annual record, and migrant departures were 60,100 in the year ended August 2017. More>>

ALSO:

Expert Reaction: Cassini's Grand Saturn Finale

After a 20 year mission, NASA's spacecraft Cassini will meet its demise this week by plunging into Saturn's atmosphere and burning up. More>>

ALSO:

Jurisdiction: Court Rejects Cathay Unit's Retirement Age Of 55 For Pilots

The Supreme Court has backed two Auckland-based Cathay Pacific pilots who claimed local law meant they couldn't be forced to retire at 55. More>>

ALSO:

Supreme Court: AFFCO Loses Lockout Appeal

The essential question in the appeal was whether those who presented themselves for work at the beginning of the 2015/2016 season were at that time “employees” for the purposes of the lockout provision... This Court has unanimously dismissed the appeal. More>>