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Frequently Asked Questions

Do any of Colorcon's product lines use acetonitrile for manufacturing operations or analytical methods?

Colorcon does not use acetonitrile in any of our production processes and is not aware of its use in any of the raw materials supplied to us. Furthermore, acetonitrile is not used in any of our routine test methods, therefore the global shortage is not expected to have a significant impact on our ability to continue business as usual. This applies to all of our liquid and powder dispersion product lines, lake pigments, PVAP, Starch 1500®, Surelease® and Sugar Sphere family of products

Are US Type IV Drug Master files confidential?

US Type IV Drug Master Files are totally confidential and have no "open" part that can be reviewed by parties other than the FDA.

Is a Certificate of Suitability (CEP) available for Colorcon dispersion products?

A Certificate of Suitability (CEP) is only available for materials that are covered by a monograph on the current European Pharmacopoeia. Therefore a CEP is not available for Colorcon dispersion products.

Where are Starch 1500® products manufactured?

Starch 1500® products are manufactured at Colorcon, 3702 E. 21st Street, Indianapolis, Indiana 46218.

Are Starch 1500® products derived from specified risk materials?

Starch 1500® products do not contain and are not derived from specified risk materials as defined in the European Commision Regulation 1326/2001 dated 29 June 2001. Starch 1500® products do not contain and are not derived from any category A, B, or C materials as defined in EMEA/410/01-Rev 2, October 2003. These products do not contain any animal materials. These products do not come into contact with any other materials of animal origin during their manufacture, packaging or storage.

Do Starch 1500® products contain any animal materials?

Starch 1500® products do not contain any animal materials. These products do not come into contact with any other materials of animal origin during manufacturing, packaging or storage.

What is the regulatory status of Starch 1500® products?

STARCH 1500® Product Codes 2001, 2001B and 2002 meet the requirements of the NF and PhEur monographs for Pregelatinized Starch. STARCH 1500® Product Code 2003 meets the NFand PhEur monographs for Pregelatinized Starch and the JPE monograph for Partially Pregelatinized Starch.

Are Colorcon products Halal certified?

Colorcon products are not Halal certified at this time.

Are Colorcon products Kosher certified?

Some Colorocon products may be certified Kosher when produced at Colorcon sites evaluated by a Rabbinical Service.

Is there a Drug Master File for Starch 1500® products?

STARCH 1500® partially pregelatinized maize starch is considered a single component product characterized by pharmacopoeial monographs and CFR regulations and as such is not included in our Drug Master File.

Is there a Drug Master File for Surelease® products?

Colorcon maintains a Type IV DMF in the United States (#9822) and a Type III DMF in Canada (DMF-2006-006) for our Surelease® products.

Is there a Drug Master File for StarCap 1500®?

Colorcon maintains a Type IV DMF in the United States (#20329) and a Type III DMF in Canada

(DMF-2007-068) for StarCap 1500®.

Are letters of reference specific to a particular drug application or submission?

Letters of reference are not specific to a particular drug application and can be used for any submission that uses the product.

Do DMF letters of reference expire?

Letters of reference do not expire and updating them is not necessary.

What information is required for a DMF reference letter?

In order to issue DMF reference letters, Colorcon requires the customer's name, address, phone number, fax number, contact person and formula number(s).

Does Colorcon provide letters of reference to their drug master files?

DMF reference letters may be requested by contacting Regulatory Affairs via the website or by email, phone or fax.

Are Colorcon products irradiated?

Colorcon products themselves are not subject to irradiation.

Does Colorcon maintain Drug Master Files for their products?

Colorcon maintains US Type IV Drug Master Files and Canadian Type III Drug Master Files for our products where applicable.

Is latex used in the manufacture of any Colorcon products?

Latex is not used in the manufacture of any Colorcon products.  Additionally, Colorcon products do not come into contact with latex during manufacture or packaging.