Market Place
Last
week, the US Food and Drug Administration (FDA) had issued a warning letter to Lantech Pharmaceuticals in India, a
contract manufacturer for companies like Aurobindo Pharma, as its cleaning
practices had created a potential for all products to contain cancer-causing
nitrosamines through mix-ups.
This week, the US agency had similar compliance concerns to share — this time over the possibility of penicillin contamination of a cancer drug made in Turkey.
The FDA issued a warning letter to Deva Holding in Turkey after a February 2019 inspection of their finished
formulation manufacturing facility. Based on the findings of the inspection,
the firm had been placed on import alert last month.
Moreover, multiple lots of its chemotherapy medication — temozolomide capsules — were recalled as they may have been cross-contaminated with beta lactam products (such as penicillin) during manufacturing.
The
FDA guidelines mandate the separation of the manufacture, processing and packaging of beta lactam
products as contamination of non-beta-lactam drugs with beta-lactam drugs (such
as penicillin) presents great risk to patient safety, including potential
anaphylaxis and death.
The warning letter said: “No safe level of penicillin contamination has been determined to be a tolerable risk. Severe allergenic responses can occur in susceptible patients exposed to extremely low levels of penicillin and other beta-lactams.”
Penicillin
detected throughout campus
Deva manufactures its drugs on two campuses in Turkey — Cerkezkoy 1 (CK1) and Cerkezkoy 2 (CK2) — that are around a quarter of a mile apart. The CK1 campus manufactures various products, including penicillin and non-beta-lactam drug products. However, the presence of penicillin was detected throughout the CK2 campus (outside the penicillin manufacturing areas) — approximately 103 times in 2017, 44 times in 2018, and nine times in 2019 (until June 2019).
Penicillin
was also detected in common areas, including dining areas, that are accessible
to employees working in both the penicillin and non-penicillin manufacturing
areas.
During
the inspection, an employee, who performed a dissolution testing demonstration,
was observed to have a stain on her clothing that was tested after she returned
from a break in the common dining area in the CK1 campus, which manufactures
various products including penicillin.
The test led the FDA to conclude that it is “unacceptable to have common areas where employees exposed to beta-lactam drugs are not isolated and separated from other employees manufacturing non-beta-lactam drugs.”
The
FDA also raised concern over the firm failing to test its non-penicillin drug
product for the presence of penicillin despite the known possibility of
cross-contamination with penicillin.
Warning
letters to Ningbo Huize, TG United
This
week, the FDA also posted warning letters to drug manufacturers in China and the United States.
At Ningbo Huize Commodity Company Limited in China, the inspectors uncovered serious data-integrity violations as they were provided with multiple documents that were falsified “for the purpose of this inspection.”
At
TG United in the USA, after an inspection that lasted almost two
months, (from December 17, 2018, to February 15, 2019) the inspectors uncovered
that the firm had failed to resolve current good manufacturing practices (cGMP)
violations from past FDA inspections in 2010, 2012, 2014, and 2017.
TG United failed to properly conduct investigations, had an inadequate water system and questionable cleaning practices. The firm’s stability program was also not adequate to demonstrate the quality of its OTC drug products through expiry.
Impressions: 1926
https://www.pharmacompass.com/radio-compass-blog/fda-warning-letter-to-turkish-firm-over-possible-penicillin-contamination-of-cancer-drug
#PharmaFlow by PHARMACOMPASS
22 Aug 2019
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Unrelated to the inspection of
the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment,
Forests & Climate Change to expand
their drug and intermediate manufacturing at three locations.
All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were
Existing Capacity
Planned Capacity
Anticipated Investment
CTO I
14.7 TPM
45.5 TPM
Rs 30 crores
CTO II
21.9 TPM
68.9 TPM
Rs 45 crores
CTO - III
4.45 TPM
28.1 TPM
Rs 12 crores
*$1 million is approximately about Rs 6.2
crores & TPM is tons per month
In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below).
Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.
Table Dr. Reddys production plans at various facilities
Product
Name
Planned
Capacity (TPM)
Facility
Location
Alendronate
Sodium Trihydrate
6.67
CTO
- III
Alfuzosin
2.33
CTO
- I
Altretamine
0.03
CTO
- I
Amlodipine
Besylate
33.33
CTO
- II
Amlodipine
Besylate
133.33
CTO
- III
Amlodipine
Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2)
100
CTO
- II
Amlodipine
Maleate
30
CTO
- III
Amsacrine
0.07
CTO
- I
Anastrazole
0.83
CTO
- II
Aprepitant
3.33
CTO
- III
Aripiprazole
0.33
CTO
- II
Atomoxetine
1.67
CTO
- III
Atorvastatin
375.83
CTO
- II
Azacitidine
0.67
CTO
- I
Bicalutamide
0.03
CTO
- II
Bivalirudin
0.03
CTO
- II
Bivalirudin
Trifluoro Acetate
0.03
CTO
- I
Bortezomib
0.03
CTO
- I
Cabazitaxel
0.02
CTO
- I
Candesartan
cilexetil
6.67
CTO
- II
Cetirizine
Hydrochloride
66.67
CTO
- I
Cetirizine
16.67
CTO
- II
Ciprofloxacin
176.67
CTO
- II
Ciprofloxacin
HCl
533.33
CTO
- II
Ciprofloxacin Lactate
33.33
CTO
- II
Clopidogrel
Bisulfate
500
CTO
- I
Clopidogrel Premix
166.67
CTO
- II
Diluted
Everolimus 5% (Everolimus)
0.33
CTO
- II
Disodium
Pamidronate
0.33
CTO
- III
Docetaxel
1.9
CTO
- I
Dutasteride
3.33
CTO
- II
Esomeprazole
magnesium
66.67
CTO
- III
Ezetimibe
3.33
CTO
- II
Fexofenadine
Hydrochloride
500
CTO
- I
Finasteride
10
CTO
- II
Fluoxetine
110
CTO
- I
Fondaparinux
Sodium
0.33
CTO
- II
Galantamine
0.03
CTO
- II
Gemcitabine
13.33
CTO
- I
Glimepiride
13.33
CTO
- II
Imatinib
0.17
CTO
- I
Irinotecan
0.33
CTO
- I
Ketorolac
66.67
CTO
- II
Lacidipine
5
CTO
- III
Lamotrigine
33.33
CTO
- I
Lansoprozole
8.33
CTO
- III
Letrozole
0.03
CTO
- II
Levocetrizine
Di HCl
10
CTO
- III
Levofloxacin
200
CTO
- II
Lomustine
1.33
CTO
- I
Losartan
Postassium
150
CTO
- I
Meloxicam
0.03
CTO
- I
Memantine
HCl
3.33
CTO
- II
Mesalamine
0.03
CTO
- II
Metoprolol
Succinate
266.67
CTO
- II
Moxifloxacin
116.67
CTO
- II
Norfloxacin
0.03
CTO
- I
Omeprazole
133.33
CTO
- III
Omeprazole
Magnesium
50
CTO
- III
Omeprazole
Sodium
10
CTO
- III
Omerprazole Form B
33.33
CTO
- III
Paclitaxel
0.33
CTO
- I
Pantoprazole
Sodium
100
CTO
- III
paroxetine
HCl
0.03
CTO
- II
Pemetrexed
0.67
CTO
- I
Rabeprazole
Sodium
83.33
CTO
- III
Raloxifene
33.33
CTO
- II
Ramipril
100
CTO
- III
Repaglinide
6.67
CTO
- II
Rivastigmine
6.67
CTO
- II
Risperidone
13.33
CTO
- I
Rivastigmine
6.667
CTO
- I
Rizatriptan
Benzoate
1.33
CTO
- II
Rocuronium
Bromide
0.03
CTO
- II
Ropinrole
HCl
1.83
CTO
- III
Rosiglitazone
3.33
CTO
- II
Sparfloxacin
3.33
CTO
- I
Tacrolimus
5
CTO
- II
Tadalafil
3.33
CTO
- II
Telmisartan
100
CTO
- II
Temozolamide
0.03
CTO
- I
Terbinafine
HCl
133.33
CTO
- III
Tizanidine
HCl
16.67
CTO
- III
Topotecan
0.07
CTO
- I
valganciclovir
0.03
CTO
- I
Vardenafil
3.33
CTO
- II
Voriconazole
8.33
CTO
- III
Ziprasidone
Hydrochloride
100
CTO
- I
Zoledronic
acid
0.33
CTO
- III
Zolmitriptan
0.83
CTO
- I
Zonisamide
0.03
CTO
- II
Impressions: 3086
https://www.pharmacompass.com/radio-compass-blog/dr-reddy-s-expansion-plans-for-api-production
#PharmaFlow by PHARMACOMPASS
03 Apr 2015
