Custom Manufacturing Quote Request Form

Product: *

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CAS#: *

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Company Name: *

Please let us know your Company's name.

Company Address: *

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Contact Name: *

Please let us know your name.

Contact Email: *

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Contact Phone: *

Please let us know your phone number. 123-123-1234

Channel:

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Intended End Use:

TopicalOralParenteralOptical Invalid Input

Generic Application:

YesNo Invalid Input

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)

Product Grade: *

Bio Pharma Grade

Bio Excipient Grade

Bio Excipient LBLE*

Bio Active Grade

Bio Active LBLE*

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*LBLE- Low Bioburden, low endotoxin

Research and Development:

Annual Volume (Kg/L):

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Per Order Volume (Kg/L):

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Size and Packaging:

Solid:

Solution:

Container:

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:

Solution:

Container:

Other:

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Timeframe for Quote: *

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Timeframe Needed for Product Availability: *

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Specifications:

MonographSpecifications to be developed by BioSpectraAttached Copy of Specification Invalid Input

Copy of Specification
(Upload PDF File):

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Target Price Point: *

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CDA:

RequiredNot RequiredCustomer ProvidedBioSpectra Provided Invalid Input

Domestic & International Requirements:

Is the product to be Marketed outside the United States?

YesNo Invalid Input

If Yes, where?

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Special Considerations:

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DMF Required?

YesNo Invalid Input

DMF Type:

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Comments:

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Captcha *

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Active Pharmaceutical Ingredients (APIs)

Biological Buffers and Denaturants (Bulk GMP)

Carbohydrates (Bulk GMP)

Excipients (Bulk GMP)

GMP Process Chemicals

Solutions (Bulk GMP)

Parenteral Ingredients, Low Bioburden, Low Endotoxin

Spec Sheets

SDS

Develop a Product with BioSpectra

Custom / Contract Manufacturing Request