Develop a Product with BioSpectra

Allow BioSpectra to partner with your organization to meet your specific needs for products and/or services. BioSpectra offers custom manufacturing of both solids and solutions, meeting your desired compliance standards and specifications, up to and including, Active Pharmaceutical Ingredients and Excipients requiring ICH Q7 GMP Compliance.

In addition to product offerings, BioSpectra provides lab testing services and regulatory support services, including DMF development.

Contact us today to begin your partnership.

Product: *
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Channel:
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Intended End Use:
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Generic Application:
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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.
Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.
Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)
Bio FUISA Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Non-Sterile Active Pharmaceutical Ingredient for use in Sterile Applications or Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a sterile Active Pharmaceutical Ingredient, Drug Product, or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)
Product Grade: *

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Research and Development:
Annual Volume (Kg/L):
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Per Order Volume (Kg/L):
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Size and Packaging:
Solid:
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Solution:
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Container:
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Other:
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Commercial Distribution:
Annual Volume (Kg/L):
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Per Order Volume (Kg/L):
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Size and Packaging:
Solid:
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Solution:
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Container:
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Other:
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Timeframe for Quote: *
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Timeframe Needed for Product Availability: *
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Specifications:
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Copy of Specification
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Target Price Point: *
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CDA:
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Domestic & International Requirements:
Is the product to be Marketed outside the United States?
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If Yes, where?
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Special Considerations:
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DMF Required?
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DMF Type:
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Comments:
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