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weliconRegulatory Approvals

At Bionext Pharma, our compliances are taken very seriously. All our pre-production approvals are fully in place before commercial production.The facility has been certified by FDA cGMP and WHO–cGMP standards and this ensures that our products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

We at Bionext Pharma are also in the process of getting few Country Specific Regulatory Board Approvals. Since we know  we are dealing in Health Care and cannot afford slip ups, we take our compliances as our Operational Guidelines rather than considering them as paper formalities.

FDA cGMP Certification

foodlogoThe Company follows the current GMP (Good Manufacturing Practices) as per revised Schedule M requirement under the provision of Indian Drugs And Cosmetics Act 1940 and rules thereunder. The facility has been certified by FDA, Maharashtra India for compliance with regards to requirement of current GMP (Good Manufacturing Practices).

WHO cGMP Certification

WHO-GMP (Good Manufacturing Practices) covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures have been taken; full traceability of a product through batch records and distribution records; and systems for recall and investigation of complaints.