A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Part 1 is a study to demonstrate that pancrelipase Delayed Release (DR) capsules manufactured
 with a Modernized Process (MP) is non-inferior to currently marketed pancrelipase DR capsules
 in participants with EPI due to Cystic Fibrosis (CF), as measured by Coefficient of Fat
 Absorption (CFA). Safety will also be evaluated. Part 2 is a study to demonstrate that
 pancrelipase manufactured with an Alternate Active Pharmaceutical Ingredient Site (AAPIS) is
 non-inferior to currently marketed active control (Creon®) in participants with EPI due to
 Cystic Fibrosis (CF), as measured by Coefficient of Fat Absorption (CFA).
Inclusion Criteria:

 -  Participant has a documented diagnosis of Cystic Fibrosis (CF) confirmed by:

 -  a sweat chloride test >= 60 mmol/L, and/or

 -  documented CF-causing cystic fibrosis transmembrane conductance regulator (CFTR)
 mutations and clinical features of CF.

 -  Participant has diagnosis of moderate to severe Exocrine Pancreatic Insufficiency
 (EPI), as determined by Fecal Elastase 1 (FE-1) < 15 μg/g at screening.

 -  Participant has EPI that is currently clinically controlled (no clinically overt
 steatorrhea or diarrhea) under treatment with a commercially available Pancreatic
 Enzyme Replacement Therapy (PERT), on an individually established dose regimen for
 more than 3 months prior to Screening, with a daily dose not exceeding 4,000 Lipase
 Units (LU)/g fat/day or 10,000 LU/kg/day.

 -  Participant is available for two (if participating in one of the parts) or four (if
 participating in both parts) hospitalization/confinement periods of 6 to 8 days each
 during the expected study window.

 -  Participant is able to consume a diet with 100 g fat/day, a minimum of 1 g/kg of
 protein/day and normal to low fiber content.

 Exclusion Criteria:

 -  BMI percentile for age less than 10% in participants less than 18 years of age.

 -  Participant has a history of any of the following gastrointestinal disorders (acute
 pancreatitis within 6 months prior to Visit 2, chronic pancreatitis, fibrosing
 colonopathy, distal intestinal obstruction syndrome (DIOS) within 6 months prior to
 Visit 2, C. difficile infection within 6 months prior to Visit 2, celiac disease,
 gastric bypass or partial/total gastrectomy, Crohn's disease or other inflammatory
 bowel disease, small bowel surgery (other than minor resection due to meconium ileus
 without resultant malabsorption syndrome), or any type of malignancy involving the
 digestive tract in the last 5 years).

 -  Participant has a history of any clinically significant endocrine, respiratory (except
 mild asthma or CF related lung disease), neurological, cardiac, renal, hepatic
 (including Hepatitis B or C), hematologic or psychiatric disease or disorder, or any
 other uncontrolled medical illness which might limit participation in or completion of
 the study.

 -  Participant requires concomitant treatment with any medication not allowed by the
 protocol or a prohibited medication is expected to be needed during the study.

 -  Participant is currently receiving nutritional supplementation via tube feeding
 (nasogastric, gastrostomy, jejunostomy).

 -  Participant has clinically significant (as per Investigator's judgment) abnormalities
 in clinical chemistry, hematology, or urinalysis (excluding findings that are
 associated with CF) such as aspartate aminotransferase (AST) or alanine
 aminotransferase (ALT) levels >= 3 times the upper limit of normal values, or
 clinically significant (investigator opinion) elevation of uric acid.