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Policy and Regulation
Regulation Explore this Topic
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Shilpa Hit With FDA Warning Letter
India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.
Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications
Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.
Podcast: The UK's New Biosimilars Licensing Pathway
In this podcast discussion, Generics Bulletin editor David Wallace talks to Duncan Emerton, director of Custom Intelligence and Analytics for Informa Pharma Intelligence, about the UK's new licensing procedure for biosimilars.
Pricing Strategies; Reimbursement Explore this Topic
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H2 Pharma Offloads Minority Interest To Private Equity
H2 Pharma, which specializes in both generic and OTC liquid formulations, is looking to climb to the next level after receiving an equity investment from Ardian.
Hikma Eyes Another Hybrid Injectable With Arecor
London-listed Hikma has signed a second partnership agreement with Arecor, proposing to co-develop a 505(b)(2) hybrid injectable product for the US market.
Shilpa Hit With FDA Warning Letter
India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.
Intellectual Property Explore this Topic
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H2 Pharma Offloads Minority Interest To Private Equity
H2 Pharma, which specializes in both generic and OTC liquid formulations, is looking to climb to the next level after receiving an equity investment from Ardian.
Hikma Eyes Another Hybrid Injectable With Arecor
London-listed Hikma has signed a second partnership agreement with Arecor, proposing to co-develop a 505(b)(2) hybrid injectable product for the US market.
Shilpa Hit With FDA Warning Letter
India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.
Market Intelligence Explore this Topic
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H2 Pharma Offloads Minority Interest To Private Equity
H2 Pharma, which specializes in both generic and OTC liquid formulations, is looking to climb to the next level after receiving an equity investment from Ardian.
Hikma Eyes Another Hybrid Injectable With Arecor
London-listed Hikma has signed a second partnership agreement with Arecor, proposing to co-develop a 505(b)(2) hybrid injectable product for the US market.
Shilpa Hit With FDA Warning Letter
India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.
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