Seda Pharma Development Services

Seda Pharma Development Services

Seda Pharmaceutical Development Services specialises in integrated Pharmaceutical Development and Clinical Pharmacology. Our mission is to facilitate the efficient development of optimal medicinal...

About the plant

Separate GMP and development facilities wity matching analytical and manufacturing equipment. The development facility contains capabilitiess for oral solid dosage forms including amorphous solid dispertions alongside conventional tablets and capsules. Oral and parenteral liquid dosage forms are also developed in this facility in addition to more complex delivery approaches such as long acting injectables and nanoparticulate systems.

The GMP facility contains 5 high potent processing rooms equipped for the manufacture of non-sterile dosage forms including ASDs, lipidic systems, tablets, capsules and powders. Packing and labelling activities can also be undertaken followed by product certification and QP release.

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Certifications

• ECOVADIS
• MHRA (UK GMP)

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Activity

• Oral liquids and semisolids, Oral solids / OSD, Injectables, Bottles, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Tablets, Hard capsules, Granules / Pellets, Powders, Lozenges, Orodispersible / Sublingual films, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Preclinical, Phase I, Phase II, Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• Controlled substance: N/A
• BSL: N/A
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (M) Musculoskeletal system, (N) Nervous system
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

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Batch Size / Reactor

• Small, Medium

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Formulation mixing, Research batches, Engineering batches, Scale-up, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Labeling, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support

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