Quality, accreditations & awards
Technical confidence.
Evidence with context.
Quality systems and regulatory documentation are part of customer qualification, not decorative badges.
Three evidence categories
Know what
each credential means.
Regulatory inspection: an outcome tied to a site, date and scope.
Certification: an issuing body, defined scope and validity period.
Award or rating: recognition of a specific achievement or assessment. It is not a regulatory approval.
Global regulatory & quality credentials
Recognised across
regulated markets.
The consolidated view brings together the regulatory credentials referenced across the website and current company materials. Applicability remains specific to the relevant site, product, filing and validity period.
Regulatory logos and references indicate the relevant authority or framework; they should not be read as blanket approval of every Morepen site or product.
Regulatory inspections
USFDA / Masulkhana
NIL Form 483
- Scope
- API manufacturing facility at Masulkhana
- Date / record
- 17 April 2026
The supplied exchange disclosure reports an inspection with no Form 483 observations, and the fourth consecutive NIL 483 inspection for Morepen. This is a dated inspection outcome, not a blanket product approval.
Dated company disclosureRead the inspection disclosureRegulatory inspections
International regulatory references
Program-specific qualification
- Scope
- Site, product and activity specific
- Date / record
- Current company materials
Company materials reference USFDA, KFDA, EDQM, PMDA, ANVISA, EU GMP, TGA, China NMPA and WHO-GMP credentials. Applicable documentation and current scope must be established for each site and program.
Scope confirmation requiredRequest scope informationCertifications
Management-system certificates
Evidence before badges
- Scope
- Site and certificate scope to be confirmed
- Date / record
- Corporate presentation references
ISO 14001, ISO 45001, ISO 50001 and ISO 37301 are referenced in the corporate presentation. Issuer, validity and scope require certificate-owner approval before publication as current credentials.
Publication approval pendingRequest scope informationCertifications
Medical Devices / ISO 13485
Separate from API credentials
- Scope
- Medical-device quality systems
- Date / record
- Supplied annual-report materials
ISO 13485 appears against Medical Devices in supplied materials. It is not a blanket API or CDMO certification; current validity and scope must be confirmed.
Publication approval pendingRequest scope informationAwards & recognition
Recognition & sustainability ratings
Historical, with context
- Scope
- Recipient, period and evidence specific
- Date / record
- Corporate materials
Corporate materials reference a 2023 workplace recognition and an EcoVadis Bronze rating. Original evidence, date, assessed entity, validity and permissions must be approved before active badges or current-rating claims appear.
Historical source referencesRequest scope informationReview build: pending records are shown to the approval team. The production feed must exclude any record without evidence, scope, validity and publication approval.
Request the right qualification package.
Identify the site, service, product and intended market so the team can confirm the relevant documentation.