Solids/Semi-Solids

Solids/Semi-Solids

In 2006, Kemwell acquired the Pfizer facility in Uppsala, Sweden, retaining all manufacturing contracts and nearly 200 people on site. The 16,000 m2, facility has over 50 years of experience in supplying pharmaceutical products to countries globally (US, Europe and Japan).

Kemwell Sweden produces and packages tablets, capsules and suppositories. Inspected by USFDA, EMA and Japanese regulatory authorities, our core process technologies include wet and dry granulation, compaction, blending and high shear mixing, fluid bed drying, tablet pressing, capsule filling, semi-solid molding, tablet coating. Kemwell has facilities and personnel to perform full service in-house quality control testing, from wet chemistry to chromatographic procedures. Experience in current cGMP guidelines and Pharmacopeias (USP/ NF, Ph. Europe/ Japan and BP)

In 2010 Kemwell increased the production area in Sweden, from 16,000 m2 to 31,000 m2 . The expansion not only makes it possible for the company to increase production of tablets, suppositories and capsules but will also allow the company to expand into other small molecule product types, based on customer demands.

Services Overview:
Manufacturing
  • Oral Solids
  • Suppositories
  • API fill into capsules, bottles
  • Clinical Trial Material (CTM) manufacture
  • Commercial Scale manufacture
Analytical Services
Clinical Packaging
  • Clinical Packaging
    1. Bottles
    2. Blisters
QP Release Testing – EU Gateway

Kemwell Biopharma – Sweden offers Qualified Person (QP) release testing for a variety of dosage forms, for pharma and biotech companies that wish to import products into the European Union (EU). Additionally, Kemwell Sweden provides QP release for our India manufacturing & clinical trial material (CTM) programs that are slated for distribution in European countries.

Stability Services
  • IND Stability testing
  • NDA Stability testing
  • ANDA Stability testing
  • Formulation prototype stability
  • Preclinical & Clinical stability
  • Method transfer and qualification
  • Stability protocol generation
  • Sample storage
  • Statistical analysis for shelf life confirmation