گاه شمار روناک
تاریخ ما را بصورت سال به سال ببینید
گاه شمار شرکت داروسازی روناک
شرکت داروسازی روناک، به مدیریت جناب آقای دکتر سعید ملکی با رسالت خدمت رسانی هر چه بیشتر به مردم عزیز ایران تاسیس گشته است .
2138
از سال 1380 تا 1382
عملیات احداث روناک با تکیه بر دانش فنی طراحی، در زمینی به مساحت 17 هزار متر مربع واقع در شهر صنعتی کاوه آغاز گردید، اعتماد به خود باوری این فرصت را فراهم نمود تا پله های رشد و توسعه تولید را یکی پس از دیگری طی کنیم.
3200
از سال 2002 تا 2003
Preparation of the primary Site Master File
Preparation of validation drafts for Water Making System and Injectable Vials Manufacturing Line
Setting up a 15-square meter fat freeze dryer
5200
از سال 2004 تا 2005
Preparation of the primary Site Master File
Preparation of validation drafts for Water Making System and Injectable Vials Manufacturing Line
Setting up a 15-square meter fat freeze dryer
7200
از سال 2006 تا 2007
Setting up Quality Assurance Department
Registration of Desfonak in Vietnam
IRFDA first audit for pre-filled syringes lines
Receiving manufacturing permission for Ciprox 200
Receiving manufacturing permission for Desfonak 500
Receiving manufacturing permission for Medrolin 500
Receiving manufacturing permission for Pepticare 40
Receiving manufacturing permission for Rofolin 30
Receiving manufacturing permission for Rofolin 200
9200
از سال 2008 تا 2009
Laboratories Calibration
IRFDA audit for Insulin lines
Preparation of the second phase of validation for Water Making System
First media fill of injectable vials
Receiving manufacturing permission for Rolexan 4000
Receiving manufacturing permission for Granisetron
1201
از سال 2010 تا 2011
Preparation of the third phase of validation for Water Making System
Takeda first audit
Receiving manufacturing permission for Rolexan 6000
Receiving manufacturing permission for Ropakin 400
Receiving manufacturing permission for Zolena
3201
از سال 2012 تا 2013
IRFDA CGMP Audit – IRFDA GMP Certificate renewal
Receiving manufacturing permission for Glamer 20 Injection
Receiving manufacturing permission for Gonarex
Receiving manufacturing permission for Menotron
Receiving manufacturing permission for Ronal F
Takeda Audit
5201
از سال 2014 تا 2015
Receiving manufacturing permission for Glamer 40 PFS
Receiving manufacturing permission for Takeda Pantazole 20 tablet
Receiving manufacturing permission for Takeda Pantazole 40 tablet
Receiving manufacturing permission for Takeda Pantazole 40 injection vial
Receiving manufacturing permission for Ronulin N and R
Receiving manufacturing permission for Roviro 250
IRFDA CGMP Audit – IRFDA GMP Certificate
7201
از سال 2016 تا 2017
Receiving manufacturing permission for Glamer 40 PFS
Receiving manufacturing permission for Takeda Pantazole 20 tablet
Receiving manufacturing permission for Takeda Pantazole 40 tablet
Receiving manufacturing permission for Takeda Pantazole 40 injection vial
Receiving manufacturing permission for Ronulin N and R
Receiving manufacturing permission for Roviro 250
IRFDA CGMP Audit – IRFDA GMP Certificate
9201
از سال 2018 تا 2019
Receiving manufacturing permission for Desfonak 2 g
Setting up new manufacturing line for injectable products leading to 100 and 200 percent increase respectively for lyophilised and solution vials
Operation of new manufacturing line for injectable products
IRFDA GMP Certificate renewal
Setting up lines for manufacturing tablets and capsules
Uganda MoH GMP Certificate
Recruiting 60 new employees
Reaching the record of manufacturing over 13 million vials and pre-filled syringes
IRFDA CGMP Audit – IRFDA GMP Certificate
Ugandan NDA CGMP Audit – Ugandan GMP Certificate
Setting up new manufacturing line for injectable products
Addition of Colistimethate Sodium 1 MU, Decarelin 0.1 mg, Cetronax 0.25 mg