ContactPrintSitemapSearchen | de

Regulatory & Toxicology

 

We at Pharma Polymers recognize that in many cases our customers intend a global marketing of their pharmaceutical products and therefore have an essential interest in the international acceptance of EUDRAGIT®. In order to ensure that our products are in compliance with current and announced regulations, we adhere to the guidelines issued in the most current compendia and regulations including, but not limited to, the United States Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur), the Japanese Pharmacopoeia (JP), Japanese Pharmaceutical Excipients (JPE). Other international regulationsand compendia are also addressed when needed. Together with our national subsidiaries, agencies and representatives, we are at all times willing and prepared to assist our customers in matters concerning registration. Whenever needed, we will provide all pertinent and helpful information.

 

Pharmacopoeial monographs

The acceptability of EUDRAGIT® polymers is documented by pharmacopoeial monographs in the US National Formulary (NF), the European Pharmacopoeia (Ph. Eur.) and the Japanese PharmaceuticalExcipients (JPE), as detailed in our leaflet "Pharmacopoeial Monographs and Drug Master Files." These monographs have been elaborated in close co-operation with Pharma Polymers. Pharma Polymers continues to actively request and support the elaboration of NF, Ph. Eur. and JPE monographs.

 

Drug master files

The entire range of EUDRAGIT® acrylic polymers is documented with the US Food and DrugAdministration (FDA) under the Drug Master File numbers stated in our leaflet "Pharmacopoeial Monographs and Drug Master Files."

Drug Master Files contain all pertinent information on the products in question. EUDRAGIT® do not have an open part. However standard information leaflets which are also included in the DMFs are available (i.e. specifications and test methods, toxicological summaries).

Since there is no blanket approval for pharmaceutical excipients, the FDA reviews the data in the Master Files every time a new drug application is submitted. In order for a customer to reference these DMFs, Pharma Polymers must send a "Letter of Authorization" to the FDA to review the file for the specific customer. Upon written request, Pharma Polymers will gladly supply the letter.

 

EUDRAGIT® L 100
  • "Methacrylic Acid Copolymer, Type A" NF
  • "Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)“ Ph. Eur.
  • "Methacrylic Acid Copolymer L" JPE
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® L 12,5
  • polymer conforms to "Methacrylic Acid Copolymer, Type A" NF
  • polymer conforms to "Methacrylic Acid - Methyl Methacrylate Copolymer(1:1)“ Ph. Eur.
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® S 100
  • "Methacrylic Acid Copolymer, Type B" NF
  • "Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)“ Ph. Eur.
  • "Methacrylic Acid Copolymer S" JPE
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® S 12,5
  • polymer conforms to "Methacrylic Acid Copolymer, Type B" NF
  • polymer conforms to "Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)“ Ph. Eur.
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® L 100-55
  • "Methacrylic Acid Copolymer, Type C" NF
  • "Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A“ Ph. Eur.
  • “Dried Methacrylic Acid Copolymer LD” JPE
  • DMF 2584 (USA)

EUDRAGIT® L 30 D-55
  • "Methacrylic Acid Copolymer Dispersion" NF
  • "Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Dispersion 30  Per Cent“ Ph. Eur.
  • "Methacrylic Acid Copolymer LD" JPE
  • DMF 2584 (USA)
  • PR-MF 8216 (Canada)

EUDRAGIT® FS 30 D
  • DMF 13941 (USA)
  • Canadian DMF 2006-176 (Canada)

EUDRAGIT® RL 100
  • "Ammonio Methacrylate Copolymer, Type A" NF
  • "Ammonio Methacrylate Copolymer (Type A)" Ph. Eur.
  • "Aminoalkyl Methacrylate Copolymer RS" JPE
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® RL PO
  • "Ammonio Methacrylate Copolymer, Type A" NF
  • "Ammonio Methacrylate Copolymer (Type A)" Ph. Eur.
  • "Aminoalkyl Methacrylate Copolymer RS" JPE
  • DMF 1242 (USA)

EUDRAGIT® RL 12,5
  • polymer conforms to "Ammonio Methacrylate Copolymer, Type A" NF
  • polymer conforms to "Ammonio Methacrylate Copolymer (Type A)" Ph. Eur.
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® RL 30 D
  • “Ammonio Methacrylate Copolymer Dispersion, Type A" NF
  • polymer conforms to "Ammonio Methacrylate Copolymer (Type A)" Ph. Eur.
  • DMF 1242 (USA)

EUDRAGIT® RS 100
  • "Ammonio Methacrylate Copolymer, Type B" NF
  • "Ammonio Methacrylate Copolymer (Type B)" Ph. Eur.
  • "Aminoalkyl Methacrylate Copolymer RS" JPE
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® RS PO
  • "Ammonio Methacrylate Copolymer, Type B" NF
  • "Ammonio Methacrylate Copolymer (Type B)" Ph. Eur.
  • "Aminoalkyl Methacrylate Copolymer RS" JPE
  • DMF 1242 (USA)

EUDRAGIT® RS 12,5
  • polymer conforms to "Ammonio Methacrylate Copolymer, Type B" NF
  • polymer conforms to "Ammonio Methacrylate Copolymer (Type B)" Ph. Eur.
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® RS 30 D
  • "Ammonio Methacrylate Copolymer Dispersion, Type B" NF
  • polymer conforms to "Ammonio Methacrylate Copolymer (Type B)" Ph. Eur.
  • DMF 1242 (USA)

EUDRAGIT® E 100
  • "Amino Methacrylate Copolymer" NF
  • "Basic Butylated Methacrylate Copolymer" Ph. Eur.
  • "Aminoalkyl Methacrylate Copolymer E" JPE
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® E PO
  • "Basic Butylated Methacrylate Copolymer" Ph. Eur.
  • "Aminoalkyl Methacrylate Copolymer E" JPE
  • polymer conforms to "Amino Methacrylate Copolymer" NF
  • DMF 1242 (USA)

EUDRAGIT® E 12,5
  • polymer conforms to "Amino Methacrylate Copolymer" NF
  • polymer conforms to -"Basic Butylated Methacrylate Copolymer" Ph. Eur.
  • DMF 1242 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® NE 30 D
  • "Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion" NF
  • "Polyacrylate Dispersion 30 Per Cent" Ph. Eur.
    ("Poly(ethylacrylat-methylmethacrylat)-Dispersion 30 %" Ph. Eur.)
  • "Ethyl Acrylate Methyl Methacrylate Copolymer Dispersion" JPE
  • DMF 2822 (USA)
  • PR-MF 6918 (Canada)

EUDRAGIT® NE 40 D
  • DMF 2822 (USA)

EUDRAGIT® NM 30 D
  • "Polyacrylate Dispersion 30 Per Cent" Ph. Eur.
    (Poly(ethylacrylat-methylmethacrylat)-Dispersion 30 %" Ph. Eur.)
  • DMF 2822 (USA)

PLASTOID® B
  • DMF 12102 (USA)