Amneal founded
Amneal opens its doors in Paterson, New Jersey.
- Manufactures first Rx product
- Files first ANDA
Amneal begins manufacturing folic acid, its first prescription product. The company also files its first ANDA as Amneal Pharmaceuticals.
- First ANDA approved
The first ANDA prepared and submitted by Amneal is approved (Metformin 500, 850 & 1000mg tablets)
- Acquires ANDAs from Merck
- Acquires ANDAs and facility from KVD
- Acquires Akyma and launches Amneal label
Amneal acquires a liquid Rx manufacturing/R&D plant in Branchburg, New Jersey, along with multiple ANDAs and product development IP from KVD.
That same year, the company acquires all assets related to five generic drugs divested by Merck KGaA and launches the Amneal label, going directly to market via its acquisition of Akyma.
- Acquires InterPharm
- Opens India R&D center
Amneal purchases Interpharm assets, including over 240,000 sq. ft. of manufacturing/R&D capacity in New York.
Later that year, celebrates the grand opening of its 75,000 sq. ft. R&D center, Amneal India.
- Becomes 12th largest generics company in the U.S. (in TRx)
IMS Health shows Amneal Pharmaceuticals as the 12th largest generics supplier in the U.S. by number of prescriptions dispensed. This same study highlights 114% year-over-year growth of the company.
- Opens consolidated, expanded distribution & sales operations in Glasgow, Kentucky
- Acquires manufacturing facility in Piscataway, New Jersey
Amneal opens a 115,000 sq. ft. consolidated distribution and sales logistics center in Glasgow, Kentucky. The company also acquires a state-of-the-art R&D and manufacturing plant in Piscataway, New Jersey, allowing further expansion into new technologies and complex, niche products.
- Acquires packaging facility in East Hanover, New Jersey
- Becomes the 7th largest generics company in the U.S. (in TRx)
IMS Health lists Amneal as the 7th largest generics company in prescriptions dispensed. Amneal acquires a 110,000 sq. ft. packaging plant in East Hanover, New Jersey to support its tremendous growth.
- FDA approves new API and FDF facilities in India
The U.S. FDA inspects and approves two Amneal facilities in India — one for manufacturing active pharmaceutical ingredients (API) and the other for finished dosage-forms.
- Acquires 1000+ MAs from Pfizer
- Acquires assets from Actavis and Warner Chilcott
- Acquires 60% of Creo Pharma
Creo Pharma in the United Kingdom is the first of many international transactions for Amneal. Creo supplies generic pharmaceuticals, commercial brands and specialist products to the pharmacy, hospital and wholesale sectors in the U.K.
- Acquires CoPharma
- Acquires Pharmagenus
- Acquires Bioeq
- Opens International HQ
To oversee its expanding global operations, Amneal opens its international headquarters in Zug, Switzerland.
- Acquires Actavis Australia
- Acquires Epsilon India
- Acquires inhalation manufacturing site in Ireland
Amneal adds to its international operations with acquisitions in Australia, India and Ireland. The 200,000 sq. ft. manufacturing facility in Cashel, County Tipperary in Ireland, is dedicated to R&D and the production of metered dose and dry powder inhalers (MDIs and DPIs) as well as biosimilars.
- Adds distribution facility in Glasgow, Kentucky
Amneal adds another distribution center in Glasgow, KY.
- Completes expansion of both New York manufacturing facilities
- Divests Amneal Australia operation
- Divests CoPharma and Pharmagenus operations
Expansion of the Amneal plant in Brookhaven, New York took the facility from 120,000 sq ft to 600,000 sq ft. in 2017.
- Amneal and Impax Laboratories combine to form a more diversified, publicly traded Amneal (NASDAQ: AMRX)
- Combination expands generics portfolio, pipeline and adds specialty business
- Formally opened our new 81,100 square foot distribution facility in Glasgow, Kentucky
- Divests Creo Pharma
- Divests Amneal Deutschland GmbH
- Expanded our Specialty CNS pipeline by signing licensing agreement with Kashiv BioSciences, LLC for the development and commercialization of orphan drug K-127 (pyridostigmine) for the treatment of Myasthenia Gravis
- Announced definitive agreement to acquire majority interest in AvKARE, one of the largest private label providers of generic pharmaceuticals in the U.S. federal agency sector
- Completed acquisition of majority interest in AvKARE, business begins operating as an independent subsidiary of Amneal serving the federal healthcare market
- Implemented sweeping COVID-19 response plan focused on prioritizing employee health and business continuity.
- Supported U.S. government’s request for medicines during COVID-19 pandemic
- Acquired WHO-certified injectables manufacturing facility in Gujarat, India
- Acquired Kashiv Specialty Pharma
- Acquired Puniska
- Operationalized new 85,000 square foot liquid manufacturing facility in New Jersey
Acquired substantially all of Kashiv Specialty Pharmaceuticals, LLC – expected to deliver substantial value for our Specialty and Generics businesses
Acquired Puniska Healthcare in Ahmedabad, India – significantly enhancing our injectables manufacturing infrastructure & capacity
- Acquired Baclofen franchise from Saol Therapeutics, expanding our institutional and specialty portfolio in neurology while adding commercial infrastructure supporting biosimilars.
- Amneal enters U.S. Biosimilars market with the approval of FYLNETRA™ (pegfilgrastim-pbbk), RELEUKO® (filgrastim-ayow) and ALYMSYS® (bevacizumab-maly)
- Launches LYVISPAH® expanding Specialty portfolio
- Completes first full-clinical NDA submission (IPX203)
- Launches First Injection Large Volume Bag
- Received first product approval in China
- Added two Biosimilars to U.S. Pipeline, Expanding Oncology Portfolio
- Signed long-term agreement with Orion to distribute Amneal Generic products in Europe, Australia and New Zealand
- Signed long-term agreement with Sterimax to distribute Amneal injectables in Canada
- Launched Third Biosimilar with FYLNETRA™ (pegfilgrastim-pbbk) in the United States
- Launched Ophthalmic portfolio in India
- Received 505(b)(2) NDA Approval from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable
- Boosted injectables capabilities to 4 facilities and 19 production lines
- Joined the community of global pharmaceutical companies listed on Nasdaq
- Announced partnership with BIAL for U.S. Licensing Agreement for ONGENTYS® (opicapone)
- Launched record number of 39 new retail and injectable products in 2023
- Entered into exclusive licensing agreements for IPX203 with Zambon Biotech for Europe and Knight Therapeutics for Canada and Latin America
- Launched ONGENTYS® (Parkinson’s Disease adjunctive therapy) in the U.S.
- Launched PEMRYDI RTU® the First Ready-to-Use Version of Important Oncology Injectable Medicine
- FDA Approval of OTC Naloxone Hydrochloride (HCl) Nasal Spray
- Launched FOCINVEZ™, the First Ready-to-Use Version of Fosaprepitant
- FDA Approval for Potassium Phosphates Injection IV Bags
- FDA Approval of IPX203 for Treatment of Parkinson’s Disease to Be Launched as CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules
- Launched CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules for Treatment of Parkinson’s Disease
- Amneal and Metsera Announce Strategic Collaboration to Develop and Supply Portfolio of Next-Generation Medicines for Obesity and Metabolic Diseases