In this week’s news, EC guides on safety feature outsourcing, FDA rejigs pandemic inspection plan and more…
Private equity interest in India CDMOs growing
Indian CDMOs are a target for private equity investors according to Global Data.
According to a report by the market analytics group contractors in the subcontinent are attracting investment as a result of “favorable government policies and a thriving generic drugs market.”
The analysts cite Advent International’s acquisition of a controlling stake in RA Chem Pharma and KKR’s investment in JB Chemicals & Pharmaceuticals as recent examples.
Global Data also says Carlyle’s acquisition of a 20% stake in Piramal Pharma and True North investment of $100m for a 2.44% stake in Biocon Biologics as other examples.
Analyst Bhavani Nelavelly said, “Both Advent and KKR have a well-established investment history in India and the recent deals reaffirm the growing interest of private equity firms in the Indian pharmaceutical industry.
“From the Piramal, JB Chemicals and RA Chem deals, it is evident that there are growing opportunities in CMO, complex generics and bulk drug manufacturers.”
EC says CDMOs can add drug safety features
The European Commission says the addition of medical safety features to drug packs can be outsourced, providing the contractor is included in the marketing authorisation.
The EC clarified its position in a revised Q&A document. It wrote, “The outsourcing of the placing of the safety features on a packaged medicinal product can be contracted to another manufacturer in line with Chapter 7 of Part I of the EU GMP Guidelines, as long as they have a manufacturing authorisation (MIA).
“The contracting manufacturer must also make a statement confirming compliance with Annex 16 Appendix 1 of the EU GMP Guidelines available to the Qualified Person certifying the final product. The contracted manufacturer must be included in the marketing authorisation.”
US FDA updates on facility inspections during Covid-19
The US FDA has issued revised guidance on how it will inspect manufacturing facilities during the pandemic.
According to the document the agency will decide whether to inspect US factories making “mission critical” products on a case-by-case basis.
Inspection of “non-mission-critical” facilities outside the US will be postponed. The agency has also put pre-approval and for-cause inspections of overseas facilities on hold for the time being.
A mission critical product is one that has been earmarked for special review – a “breakthrough therapy” or “regenerative medicine advanced therapy” or one that treats a disease for which “there is no other appropriate substitute.”
Also in the news
Coronavirus vaccine developers face considerable challenges, including how to make millions of doses as rapidly as possible. Read the full Politico report.
The Covid-19 pandemic has had a profound and lasting impact on clinical trial materials supply chains according to DCAT.
Inside Health Policy reports the US Government is reviewing FDA guidance on controlling the levels of nitrosamine impurities in drugs. Read more here.
Reuters reports that the WHO is struggling to develop a worldwide plan for a SARS-CoV-2 vaccine.
US politicians have asked the US International Trade Commission to look into COVID-19 medical technology supply chain barriers. Read more at Medtech.
Some developments of note in the contracting sector:
Pfizer has joined the list of firm’s making Gilead’s candidate antiviral remdesivir which is being tested as a Covid-19 treatment.
Ajinomoto bio is expand its small molecule manufacturing capacity. The CDMO started building a production facility in Visakhapatnam, India last month. The plant is scheduled to be operation in mid-2022.
Navidea Biopharmaceuticals has signed a license and distribution deal with Jubilant Draximage. Jubilant will distribute Navidea’s Rheumatoid Arthritis diagnostics in the US, Canada, Mexico, and Latin America. See press release.
OutsourcedPharma spoke with Pii CEO Kurt Nielsen about what US CDMOs can learn from BASF’s “verbund” approach to combined manufacturing operations.