Darou Darman Arang is a fast growing pharmaceutical Company in Iran.
Darou Darman Arang is a fast growing pharmaceutical Company in Iran.
We are a fast growing pharmaceutical company manufacturing our own brands and representing pharmaceutical companies from around the world in Iran to import medicines.
DAROU DARMAN ARANG acts as the representative agent for specialty, rare disease, biotech and vaccine producing companies looking to penetrate to Iran. We are the preferred strategic partner, providing turn-key solutions and support for their commercial operations…… Read more
We have ensured world-class quality in design, equipment and operations in our manufacturing facility. Our units ensure that we are able to provide best-in-class products to patients across the Iran and emerging markets around. Our manufacturing operations are focused on producing generics and branded generics, in the full range of dosage forms, including tablets, capsules, injectable, pre-filled syringe and freeze dried powder. …… Read more
Imports of Finished Pharmaceuticals
As the pioneer of our mission to meet the needs of the health society across IRAN and beyond with our expert staffs and facilities to import different health care products…… Read more
We in R&D department aimed to Reach to various market requirements and high quality products, by representing formulation and providing new method analysis, taking advantage of experienced Experts, using the most up to dated sources of pharmaceuticals and advanced devices. In addition to exploitation of cooperation and consultation of prominent University professors and other authentic science centers.
Read MoreRegulatory
Having sufficient knowledge of drug registration rules & regulations for registration of products
Adequately capability of registering new products in the Drug National List
Well knowledge of the drug, raw material and food supplement approval process and registration bureaucracy in Ministry of Health
Submitting registration documents to MOH
DAROU DARMAN ARANG COMPANY WAS ESTABLISHED BY A GROUP OF EXPERIENCED PEOPLE TO ATTRACT, DEVELOP AND DELIVER NEW CAPABILITIES.
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review its marketing authorization application for SB11, a biosimilar of Lucentis® (ranibizumab). If successful, this will be the first Lucentis® biosimilar available in Europe.
Regulatory guidelines for biosimilar approval have existed in Europe since 2004. These are based on the totality of evidence from comparative studies with reference products and have always required comparative efficacy studies. However, a recent article by Bielsky et al., published in Drug Discovery Today [1], explores the increasingly questioned role of the clinical efficacy trial in biosimilar approval.
Companies seeking to commercialize orphan drug biosimilars are likely to face challenges associated with limited potential market size, uncertainty regarding expanding patient access and loyalty to the reference product.
