Erregierre

Erregierre is an Italian active pharmaceutical ingredient (API) manufacturer founded in 1974 by the chemist Pietro Gargani. The company is based in San Paolo, Italy, and has built its reputation on the production of medium-to-small volumes of small-molecule APIs for both human and veterinary use. Its flexible, multipurpose industrial setup is designed to serve pharmaceutical companies that need reliable supply of niche or lower-volume molecules, an area where large-scale producers are often less responsive. Erregierre's portfolio covers a wide range of therapeutic classes, including antihypertensives, antidepressants, antipsychotics, antifungals, anticoagulants, anti-inflammatories and treatments for Alzheimer's disease and ulcerative colitis. The company supports customers with regulatory submissions, including Drug Master Files (DMFs) and dossiers, in highly regulated markets such as the United States, Europe, Japan and South Korea. Its first FDA inspection dates back to 1974, the same year the company was founded, and it has been active in the Japanese market since 2000. Over the decades Erregierre has expanded its manufacturing capacity and compliance infrastructure. In 2001 it acquired the Sovere site, increasing capacity by 40%. Between 2011 and 2014 it obtained ISO 14001 and OHSAS 18001 certifications for environmental and safety management, and in 2013–2016 both of its sites were approved by the Italian Veterinary Health Authority. In 2018 the company adopted a Code of Ethics and a formal Compliance Program. Erregierre remains a privately held Italian company, positioning itself as a dependable partner for pharmaceutical companies navigating complex and uncertain API supply chains. Its combination of regulatory expertise, medium-small volume specialization and long-standing relationships with regulated markets defines its market identity.

Erregierre was founded in 1974 by Pietro Gargani, a chemist described by the company as visionary. From its base in San Paolo, Italy, the company focused on the production of active pharmaceutical ingredients (APIs) for both human and veterinary applications. Its first FDA inspection also took place in 1974, an early sign of its orientation toward regulated international markets. Through the 1970s and 1980s Erregierre built a reputation as a supplier of medium-to-small volumes of small-molecule APIs, a segment often underserved by larger manufacturers. The company's flexible, multipurpose plants allowed it to handle a diverse portfolio of molecules and to respond quickly to customer needs. In 2001 Erregierre acquired the Sovere manufacturing site, which increased its production capacity by approximately 40%. This acquisition marked a significant expansion of its industrial footprint and supported its growth in regulated markets. The company had been active in Japan since 2000, and it continued to serve customers in North America, Europe and other regions. Between 2011 and 2014 Erregierre achieved ISO 14001:2004 certification for environmental management and OHSAS 18001:2007 certification for occupational health and safety. In 2013–2016 both of its sites were approved by the Italian Veterinary Health Authority, reinforcing its position in the veterinary API segment. In 2018 the company adopted a Code of Ethics and a formal Compliance Program, reflecting its commitment to regulatory and ethical standards. Today Erregierre presents itself as a reference point for customers navigating the small-medium volume supply chain, offering regulatory support for DMF and dossier submissions in the United States, Japan, South Korea, Europe and other highly regulated markets. With more than 50 years of experience, it continues to operate as a privately held Italian API manufacturer.

• 2018

  Adoption of a Code of Ethics and a formal Compliance Program.

• 2016

  Completion of Italian Veterinary Health Authority approvals for both sites.

• 2014

  OHSAS 18001:2007 certification for occupational health and safety.

• 2013

  Approval of sites by the Italian Veterinary Health Authority (process spanning 2013–2016).

• 2011

  ISO 14001:2004 certification for environmental management.

• 2001

  Acquisition of the Sovere site, increasing capacity by 40%.

• 2000

  Active in the Japanese market since 2000.

• 1978

  First FDA inspection (as listed in company history).

• 1974

  Erregierre is founded by Pietro Gargani; first FDA inspection takes place.

Specialist in medium-small volume small-molecule APIs with strong regulatory support for highly regulated markets.

• Acebutolol HCl

• Ambroxol HCl

• Aripiprazole

• Bifonazole

• Bisacodyl

• Bupropion HCl

• Butenafine HCl

• Camostat Mesylate

• Ciclopirox

• Ciclopirox Olamine

• Clotrimazole

• Econazole Nitrate

• Eltrombopag Olamine

• Fluoxetine HCl

• Fonturacetam

• Isoconazole Nitrate

• Isoxsuprine HCl

• Mebhydrolin Napadisilate

• Mesalamine (5-ASA)

• Miconazole Nitrate

• Moclobemide

• Naftifine HCl

• Nisoldipine

• Opipramol 2HCl

1. 1Erregierre – Over 50 Years of API Excellenceerregierre.it
2. 2Erregierre – Historyerregierre.it
3. 3Erregierre – API Portfolio for Human and Veterinary Useerregierre.it
4. 4Wikidata – Erregierrewikidata.org