2001
Operational Foundations
Preparation of operational methods for Regulatory & Quality Control Departments.
2002-2003
Preparation & Validation
Primary Site Master File prepared. Validation drafts for Water Making System and Injectable Vials Line. Setup of 15 m² fat freeze dryer.
2004-2005
Early Manufacturing
First Pepticare batch produced on injectable vial line. IRFDA CGMP first audit passed, certificate received. Manufacturing permission for Ronulin N & R.
2006-2007
Quality & Regulatory Development
Quality Assurance Department established. Registration of Desfonak in Vietnam. IRFDA first audit for pre-filled syringe lines. Manufacturing permissions for Ciprox 200, Desfonak 500, Medrolin 500, Pepticare 40, Rofolin 30 & 200.
2008-2009
System Validation & Audits
Laboratories calibration and IRFDA audit for insulin lines. Phase II validation preparation for Water Making System. First media fill for injectable vials. Manufacturing permissions for Rolexan 4000, Granisetron.
2010-2011
Product Expansion
Preparation of Phase III validation for Water Making System. First audit by Takeda. Manufacturing permissions for Rolexan 6000, Ropakin 400, Zolena.
2012-2013
New Product Approvals
Manufacturing permissions for Glamer 20 Injection, Gonarex, Menotron, Ronal F. IRFDA CGMP audit and certificate renewed. Takeda audit performed.
2014
Production Lines & Approvals
Production Lines: Vial Filling · Lyophilized Vials · Pre-filled Syringes Regulatory: Manufacturing permissions for Glamer 40 PFS, Takeda Pantazole 20 & 40 tablets, Takeda Pantazole 40 injection vial, Ronulin N & R, Roviro 250. IRFDA CGMP audit and certificate renewed.
2015
Production Lines Expansion
Production Line 2 – Injectable Products: Vial Filling (Solution Vials): 3-100 mL, 20 million vials/year. Lyophilized Vials: 14 million vials/year. Products: Lyophilized and solution injectable products.
2016-2017
Solid & Injectable Product Growth
Preparation for expansion of sterile lines and solid dosage manufacturing. Secondary packaging of Takeda Pantazole. Manufacturing permissions for Colistimethate Sodium 1 M IU, Protamine Sulphate, Rofend 200, Rofolin 100. IRFDA GMP certificate renewed. New products added: Gonarex, Menotron, Ronal F.
2018-2019
Major Expansion & Record Production
New injectable manufacturing line established, resulting in 100% and 200% growth in lyophilized and solution vials. Achieved record production of over 13 million vials and pre-filled syringes. IRFDA GMP certificate renewed; Ugandan NDA CGMP audit passed. Manufacturing permission for Desfonak 2 g. Added products: Colistimethate Sodium 1 MU, Decarelin 0.1 mg, Cetronax 0.25 mg. 60 new employees recruited.
2018-2024
Advanced Production Lines
Solid Dosage Forms (Capsules & Tablets): ~550 million tablets, 83 million capsules/year. Botulinum Toxin A Line: ~10 million vials/year. API Production Line: Risdiplam API (capacity not available). Production Line 3 – Injectables: solution, lyophilized, powder (capacity not available). Softgel Line: 100 million softgels/year. Injectable Anticancer Line: Under construction. Solid Dosage Anticancer Line: Capsules & tablets (capacity not available).
2021-2025
COVID-19 Response
First company in Iran to produce Remdesivir for hospitalized COVID-19 patients. Production of over 200,000 vials/month with quality comparable to the original brand, at a lower price. Ensured: Easy access to medication Reduced medical expenses Prevention of currency outflow Production Line 4 – Injectables: ~40 million ampoules/year.