The US FDA has cleared Lupin to restart production of drugs for the US market at its plant in Goa after the Indian firm fixed problems observed by agency inspectors.
Increasing demand for reduced particle loads in pharmaceutical containers has driven Datwyler to build a CHF 100m plant making elastomer components for injectable drug delivery systems.
Data integrity issues and the unexplained disappearance of drums of pharmaceutical ingredients have landed a Chinese API maker with a US FDA warning letter.
The US FDA wants more information on Czech API firm Interpharm Praha AS’s efforts to prevent repetition of data manipulation uncovered during 2015 inspection.
APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US Food and Drug Administration (FDA).
The US FDA has issued fours warnings against foreign drugmakers, citing reasons including problems with QC, a non-registered facility, and finished products that “did not contain any of the labeled active ingredient.”
French regulators have recommended that drugs containing APIs made at Nandu Chemicals Industries’ site in Hubli, India be recalled after uncovering “serious” problems during an inspection in August.
Nippon Fine Chemical staff formed a human barricade to prevent a US FDA team inspecting a quality control laboratory at its site in Takasago City, Japan according to a warning letter published this week.
Cheng Fong Chemical has addressed problems at its Taoyuan City plant but still needs to identify the source of foreign matter found in its APIs according to the US FDA.
Shire says it will appeal a decision invalidating a patent surrounding the controlled-release composition of its ulcerative colitis drug Lialda (mesalazine).
Xinxiang Tuoxin Biochemical has received a US FDA warning letter after manufacturing equipment at two API facilities were found to be in a state of disrepair.
The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.
The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.
Pfizer supplier Zhejiang Medicine Co. should quiz staff to determine the extent of data integrity deficiencies at its API plant in Xinchang, China according to the US FDA.
WuXi AppTec has announced that its Jinshan Shanghai-based small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility has passed its third US FDA inspection.
Teva has recalled an injectable antibiotic that is one of only two products currently made at the Godollo, Hungary facility that was hit with a US import ban in May.
Steroid API firm Gadea Pharmaceuticals helped AMRI grow revenue in the second quarter offsetting flat royalties and the impact of the closure of its site in Holywell, Wales.
The US FDA says Xiamen Origin Biotech Co. lied to investigators during an inspection of its API facility in Fujian in which significant deviations from cGMP were identified.
US FDA warnings and Venezuela's economic crisis have contributed to “a challenging quarter” for Dr Reddy’s, with its API business being particularly affected.
The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.
The US FDA has drug manufacturer Cheryl Laboratories from shipping products to the US after the CMO stopped inspectors from visiting its facility in Navi Mumbai, India.
The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.
The Taiwanese drugmaker stopped shipping products to the US after an FDA inspection but failed to commit to corrective actions, states a warning letter published this week.
The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.
The US FDA says Ko Da Pharmaceutical facility in Taoyuan City, Taiwan will not be able to supply the US unless the firm corrects all GMP deviations identified during an inspection last May.
