Nigeria Tightens API Sourcing Norms For Finished Pharma Products

Hyderabad: “Pharmaceutical companies and manufacturers must prioritise sourcing APIs from reputable suppliers while adhering to stringent quality control measures to ensure the highest standards in their products,” Nigerian regulator National Agency for Food and Drug Administration and Control said, listing the approved sources and setting timeline for compliance.

While January 2024 was when the directive came into force for those submitting dossiers for product registration, companies with registered finished pharmaceutical products (FPPs) who have not sourced the APIs or excipients from listed sources are required to comply by January 2027, it said in a communication that Pharmaceuticals Export Promotion Council of India has circulated to its members.

Nigeria is 10th largest pharma export destination for India. Pharma exports to Nigeria increased 2.65% from $573.17 million in 2020-21 to $588.34 million in 2021-22. In 2022-23, it declined 12.30% to $515.96 million or 2.03% of the total pharma exports from India, Pharmexcil data shows.

Related Posts

Aurobindo Pharma gains after receving USFDA nod for Glycerol Phenylbutyrate Oral Liquid

Aurobindo Pharma announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per ml. The…

Legal Loopholes Stall Crackdown On Interstate Fake Drug Rackets In India

New Delhi: Serious legal gaps in the Drugs and Cosmetics Act, 1940, combined with acute shortages of manpower and infrastructure, continue to impede the Central Drugs Standard Control Organisation (CDSCO)…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

Aurobindo Pharma gains after receving USFDA nod for Glycerol Phenylbutyrate Oral Liquid

Aurobindo Pharma gains after receving USFDA nod for Glycerol Phenylbutyrate Oral Liquid

Legal Loopholes Stall Crackdown On Interstate Fake Drug Rackets In India

Legal Loopholes Stall Crackdown On Interstate Fake Drug Rackets In India

Patna HC Rules Phenothiazine & Promethazine Not Narcotic Or Psychotropic Substances Under NDPS Act

Patna HC Rules Phenothiazine & Promethazine Not Narcotic Or Psychotropic Substances Under NDPS Act

COMT Inhibitors May Fuel Gut Bacteria That Degrade Levodopa In Parkinson’s Patients

COMT Inhibitors May Fuel Gut Bacteria That Degrade Levodopa In Parkinson’s Patients

Delhi Crime Branch Seizes Huge Stock Of Expired Baby Food, Cosmetics; One Arrested

Delhi Crime Branch Seizes Huge Stock Of Expired Baby Food, Cosmetics; One Arrested

FDA Releases Draft Guidance To Validate Non-Animal Testing Methods (NAMs) In Drug Development

FDA Releases Draft Guidance To Validate Non-Animal Testing Methods (NAMs) In Drug Development