Development and GMP production of pharmaceutical active ingredients, fine chemicals and intermediates since 1953.
Chemische Fabrik Berg GmbH
Bitterfeld-WolfenNew on Amplifa
Company
Chemische Fabrik Berg GmbH is a mid-sized manufacturer of pharmaceutical active ingredients (APIs), fine chemicals and chemical intermediates located in Bitterfeld-Wolfen with around 100 employees. The company supports customers along the entire process: from feasibility studies through process development and scale-up to GMP-compliant production at kilogram to campaign scale with production volumes from kilograms to over 100 tonnes per year and approximately 50 m³ of reactor capacity. The offering includes custom synthesis (custom manufacturing), contract synthesis (including alkylations, cyclizations, cyanations, hydrogenations, quaternizations, salifications, saponifications), GMP micronization in a Class D cleanroom with a spiral jet mill (0.5–10 µm) as well as packaging and repackaging of highly potent and highly toxic substances in an ISO 8 cleanroom. Key focus areas are pyrimidine chemistry and controlled substances such as barbiturates and thiouracils. In addition, CFB supports customers with registration and approval with around 20 maintained DMFs in more than 30 countries. As a member of the Moehs Group, the company is integrated into a European network of specialised production sites and supplies human and veterinary pharmaceutical customers worldwide.
- Site
- Bitterfeld-Wolfen
- Processes
- Contract synthesis (custom manufacturing), Alkylation, Condensations / cyclizations (malonate esters + urea derivatives to barbiturates), Condensations / cyclizations (dicarbonyl compounds + thiourea derivatives to thiouracils), Cyanations, Hydrogenations, Quaternizations (quaternary ammonium compounds), Salifications (e.g. hydrochlorides)
- Materials
- Active pharmaceutical ingredients (APIs), Fine chemicals, Quaternary ammonium compounds, chemical intermediates, Active pharmaceutical ingredients, Pyrimidine chemistry / Barbiturates & thiouracils
- Certificates
- GMP, GMP certificate
- Founded
- 1953
- Employees
- approx. 100
- Industries
- Pharmaceutical industry (human and veterinary medicine)
- 01
Process development & scale-up
- 02
Contract synthesis
- 03
GMP production
- 04
Micronization (Class D cleanroom)
- 05
HPAPI packaging (ISO 8 cleanroom)
- 06
Registration & approval
Products & Processes
Active pharmaceutical ingredients
GMP-compliant active ingredients for human and veterinary medicine, including sedatives, anesthetics and endocrinology products.
Fine chemicals
Fine chemicals and chemical intermediates for the pharmaceutical industry.
Quaternary ammonium compounds
Traditional product segment based on many years of synthesis experience.
Pyrimidine chemistry / Barbiturates & thiouracils
Specialisation in complex multi-stage syntheses such as condensations of malonate esters to barbiturates and of dicarbonyl compounds to thiouracils.
Locations
Bitterfeld-Wolfen
DEProduction and administration (headquarters)
- Lot size
- Laboratory to campaign scale
- Materials
- APIs, fine chemicals, intermediates
- Reactors (~50 m³ total capacity)
- Pilot plant for scale-up under GMP conditions
- Spiral jet mill (micronization, Class D cleanroom)
- Wastewater and exhaust air treatment systems
Products
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Contract synthesis (custom manufacturing)Other (chemical synthesis) | – | – | kg – >100 t/year | – | APIs, fine chemicals, chemical intermediates |
| AlkylationOther (chemical synthesis) | – | – | – | – | Alkyl halides (X = Br, Cl), Alkyl/aryl/phenyl substrates |
| Condensations / cyclizations (malonate esters + urea derivatives to barbiturates)Other (chemical synthesis) | – | – | – | – | Malonate esters, Urea/thiourea/guanidine derivatives |
| Condensations / cyclizations (dicarbonyl compounds + thiourea derivatives to thiouracils)Other (chemical synthesis) | – | – | – | – | Dicarbonyl compounds, Thiourea derivatives |
| CyanationsOther (chemical synthesis) | – | – | – | – | Sodium cyanide, Formamides |
| HydrogenationsOther (chemical synthesis) | – | – | – | – | Tetrahydrofuran synthesis substrates |
| Quaternizations (quaternary ammonium compounds)Other (chemical synthesis) | – | – | – | – | Amines, Alkyl halides (X = Br, Cl, OH) |
| Salifications (e.g. hydrochlorides)Other (chemical synthesis) | – | – | – | – | – |
| Saponifications (carboxylate esters to carboxylic acids)Other (chemical synthesis) | – | – | – | – | Carboxylate esters (R = aryl, phenyl) |
| Process development & scale-upEngineering | – | – | – | Laboratory scale – industrial production | chemical intermediates, APIs |
| Micronization (GMP, Class D cleanroom)Other (processing) | – | – | – | – | APIs, controlled substances |
| HPAPI packaging/filling (ISO 8 cleanroom, DIN EN ISO 14644-1)Other (packaging) | – | – | a few grams – several kilograms | – | highly potent and highly toxic substances |
| GMP-compliant production of pharmaceutical active ingredientsOther (pharmaceutical manufacturing) | – | – | kg – >100 t/year | – | APIs, fine chemicals, intermediates |
| Registration & approval (DMF, CEP, ~20 DMFs, >30 countries)Engineering | – | – | – | – | – |
4 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Spiral jet mill (micronization) | – | – | – | – | Bitterfeld-Wolfen |
| Reactors (chemical production) | – | – | ~50 m³ total reactor capacity | – | Bitterfeld-Wolfen |
| Pilot plant (scale-up under GMP conditions) | – | – | – | – | Bitterfeld-Wolfen |
| Wastewater and exhaust air treatment systems | – | – | – | – | Bitterfeld-Wolfen |
Additional services
Quality & Regulatory
GMP-certified since 2000, with regular inspections by national and international authorities (including BfArM, US FDA, KFDA, Anvisa, PMDA) as well as customer audits. External audits independently documented.
| Evidence | Bitterfeld-Wolfen |
|---|---|
| GMP certificate |
History
- 1953
Founded by Dr. Herbert Berg within a metalworking family business in Lüdenscheid; initially adhesive manufacturing.
- 1998
Relocation to Bitterfeld-Wolfen (site with a chemical tradition)
- 2000
First GMP certification
- 2003
Part of PMC Global Inc.
- 2009
Integration into the Moehs Group