DDReg Pharma

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DDReg Pharma

Case Studies

Gulf Health Council file upload for biosimilar product

One of the top three biopharmaceutical companies approached DDReg to get the dossiers for their product submitted to the Gulf Health Council (GHC). The challenge was to publish and submit the large size files to the GHC portal (Taawon) while running against the time.As the team finished the grueling job of publishing the sections of …

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Introduction of Indian Herbal Pain Patch in the USA

Introduction of Indian Herbal Pain Patch in the USA Manufacturer of a very popular Menstrual Pain Patch with herbal ingredients wanted to introduce the product in USA. The product had herbal constituents sourced from India. With very strict US FDA requirements for importing and selling medicinal products in USA, the company wanted to have the …

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Development of all-inclusive “Global” DMF

Development of all inclusive “Global” DMF Agencies across the emerging markets have been dealing with lot of ambiguities pertaining to Active Substance. These ambiguities emanate when a number of applicants submit diverse active substance information or Drug Master files (DMFs) on the same active by the same Active supplier (DMF Source). This usually happens when …

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Biosimilar Market Authorization in Malaysia

Biosimilar Market Authorization in Malaysia Unlike most small-molecule drugs, which are chemically synthesized with highly predictable structures and functions, biologics and biosimilars are pharmaceutical compounds synthesized or extracted from a biological source, often with much more complex structures. Thus, unlike generic medicines in which the active ingredients are identical to the reference small-molecule drug, biosimilars …

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UK registration of a formulation of a big global brand, sourced from 3rd party CMO

UK Registration of a Formulation of a Big Global Brand sourced from 3rd party CMO A UK-based global CHC organization wanted to seek MA for a Fixed Dose Combination analgesic formulation. The product was sourced from a 3rd party CMO.Usually, the 3rd party sourcing is required when the in-house pipeline not able to support markets …

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